SurModics is a leading provider of surface modification technologies for the healthcare industry. With a history dating back to 1979, the company has been at the forefront of developing innovative solutions to enhance medical devices and improve patient outcomes. SurModics' cutting-edge technologies are used in a wide range of applications, from drug delivery systems to diagnostic assays, making a significant impact in the field of healthcare.

Operator 1

Senior Design Assurance Engineer

Process Development Engineer

Senior R&d Sustaining Engineer

Territory Manager - Phoenix Area

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Senior Field Clinical Specialist (SFCS) is responsible for utilizing their clinical and technical expertise for training, education, and establishing practice standards that incorporate Company products into the customer’s clinical environment. &nbsp;The individuals in this role take new product concepts and existing medical devices into customer sites to obtain product feedback and clinical experience which includes identifying customer needs, capturing product-related feedback, and evaluating competitive differentiation. &nbsp;The SFCS’s must objectively translate this feedback to product development and business teams to inform product design decisions and improvements.&nbsp; Responsibilities&nbsp; Clinical Support (70%) • &nbsp; &nbsp;Train, educate and support HCPs on the clinical use of company products• &nbsp; &nbsp;Support clinical sites to complete product evaluations; Provide customer, clinical, and technical support&nbsp;• &nbsp; &nbsp;Obtain and translate customer / clinician feedback to internal teams to inform product design decisions and improvements• &nbsp; &nbsp;Deliver product presentations (one-on-one or group in-services), provide clinical expertise as it relates to product usage in indicated clinical procedures• &nbsp; &nbsp;Establish standards of practice involving company products within clinical and customer sites• &nbsp; &nbsp;Act as clinical liaison between product/business teams and end-user customers• &nbsp; &nbsp;Lead and coordinate lunch &amp; learns, educational events, training symposia and regional conferences as appropriate• &nbsp; &nbsp;Act as a trusted advisor and identify champions, build strong relationships with customers and colleagues• &nbsp; &nbsp;Actively participate in developing training programs and materials related to anatomy, disease states, and products for both internal and external customers• &nbsp; &nbsp;Adhere to company standards and values related to honesty, integrity, trust, respect, and accountability. Perform all responsibilities in accordance with company policies and procedures and applicable state / federal rules and regulations Functional Requirements and General Accountabilities (30%) • &nbsp; &nbsp;Participate in all required training as well as clinical and/or sales meetings, tradeshows, conferences, as needed• &nbsp; &nbsp;Maintain sample inventories, distributing samples in compliance with sample accountability procedures and policies&nbsp;• &nbsp; &nbsp;Provide complete, accurate and timely submission of all documentation to include but not limited to timekeeping, customer interactions - site visit details, customer complaints, call activity logs, expense reports, and consignment and sample tracking• &nbsp; &nbsp;Maintain and update current and prospective customer target profiles • &nbsp; &nbsp;Stay current with market knowledge and competitive products and share knowledge internally• &nbsp; &nbsp;Maintain understanding and full compliance to company compliance programs and policies. Operate within industry guidelines related to AdvaMed, Sunshine Act, and other regulations that provide a framework for appropriate interaction with healthcare professionals• &nbsp; &nbsp;Comply with Promotional Programs, and proper use of Promotional Materials and Promotional Expense Budgets Required Skills and Abilities • &nbsp; &nbsp;Polished professional presence and ability to interact and relate well to physician and nursing community, educators, and other healthcare professionals• &nbsp; &nbsp;Confidence in demonstrating medical devices and discussing procedure-related topics• &nbsp; &nbsp;Ability to successfully give presentations and workshops to medical professionals• &nbsp; &nbsp;Collaborative / Dedicated to teamwork – integrates well with product development, marketing, and sales team.• &nbsp; &nbsp;Comfortable in Cath-lab setting in hospital, ASC and OBL&nbsp;• &nbsp; &nbsp;Organized and responsive to company and customer needs• &nbsp; &nbsp;Self-motivated and directed; ability to take initiative and adapt to fast-changing environment• &nbsp; &nbsp;Masters new technology quickly; strong attention to detail and technical success factors• &nbsp; &nbsp;Strong interpersonal skills and ability to build effective and lasting relationships with customers• &nbsp; &nbsp;Excellent public speaking and communication skills (written and verbal) Minimum Qualifications • &nbsp; &nbsp;Bachelor’s degree required, medical technology, biology, chemistry, or other life sciences preferred• &nbsp; &nbsp;5-7 years of experience in radial access and/or thrombectomy procedures preferred• &nbsp; &nbsp;5-7 years of clinical experience• &nbsp; &nbsp;Experience working with CRM software• &nbsp; &nbsp;Experience partnering with Sales Team&nbsp;• &nbsp; &nbsp;Willingness to travel (75%) with 2-3 overnight stays a week – throughout region and U.S.• &nbsp; &nbsp;Ability to work a flexible schedule that may change on short notice due to customer needs Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$112,500&mdash;$168,600 USD

Senior Field Clinical Specialist  - Michigan Area

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Design Assurance (DA) Manager is responsible for providing quality engineering support for all phases of product development, driving post market assessment activities, and supporting consistent design through production release and commercialization. The DA Manager will be responsible for ensuring staffing and successful execution for all projects assigned to the DA team. The DA Manager will also serve as a working team member in the execution of product development process (PDP) deliverables for complex projects. The DA manager will own development/improvements for procedures in the areas of Design Control and Risk Management and serve as a corporate-wide SME, major contributor and key influencer on Design Controls, Risk Management and Post Market Surveillance activities. Responsibilities Management Develops and maintains a solid team environment through effective hiring, communication, recognition, feedback and development• Working manager that both manages the team and serves a design assurance function for assigned teams or projects• Monitors, directs, and prioritizes staff workload to ensure business objectives are met• Contributes to establishing overall Quality department yearly goals and objectives• Advises planning for department resource needs• Foster a department culture of pertaining to Surmodics mission and 5C values• Responsible as primary interface for internal audits, regulatory body audits for responsible areas• Determine appropriate staff levels and schedules while working with key partners to understand priorities and plan resource allocation accordingly• Provides mentoring and coaching for less experienced staff Product Development Team Member • Serve as DA Lead (Core Team member) on cross-functional PDP team• Provide subject matter expertise and leadership in the area of Design Controls and Risk Management• Understand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologies• Lead execution of risk management activities for PDP projects• Develop Design Verification, Design Validation, and Usability plans, protocols and reports• Develop and execute or oversee test method validations• Plan post market activities for the project through development of PMS Plan, Field Assessment Plan and support of Clinical Evaluation, clinical literature review and PMCF studies• Understand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies.• Lead problem solving activities, failure investigations, and CAPA activities• Support design transfer activities including process validation and material qualifications.• Serve as project manager for the project or specific area of the project, if requested.• Provide subject matter expertise for assigned projects in audits• Balance complex performance, regulatory, and manufacturing requirements to achieve most optimal solution for the project. Post Market • Lead planning and facilitate execution of post market surveillance activities• Lead complaint investigations in the categories of risk assessment investigations• Generate Field Assessment and Post Market Surveillance reports• Analyze engineering change requests• Support process and design change activities• Address regulatory standards gap assessments to maintain product compliance Quality Systems • Drive improvements to the design control, post-market surveillance, risk management, and any other assigned processes to ensure ongoing compliance• Develop and maintain key quality metrics and drive improvements• Develop risk-based procedures and instructions throughout the quality system• Present trending data to management during management review• Review current regulations and requirements and recommend changes to quality system• Provide Quality Representation for NCMR, Complaints, internal and external audit findings and CAPAs Minimum Qualifications • BS or advanced degree in technical discipline, engineering preferred• 3+ years management experience• 8+ years overall medical device experience• 8+ years’ experience in DA or Quality Engineering function• Extensive experience with QSR and ISO regulations• Extensive experience with statistical techniques, measurement/trending and SPC tools• Demonstrated technical expertise and leadership in Quality• Strong ability to communicate (written and verbally) within and across disciplines and organizational structures• Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment• Self-starter, with the ability to manage multiple tasks and tight timelines• Demonstrated use of tools and methodologies within a Quality System• High attention to detail, organization, and accuracy• Excellent analytical and problem solving skills• Proficient computer skills- Microsoft Word, Access and Excel, statistic software(jmp, minitab) Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$112,500&mdash;$168,600 USD

Design Assurance Manager

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Field Clinical Specialist (FCS) is responsible for utilizing their clinical and technical expertise for training, education, and establishing practice standards that incorporate Company products into the customer’s clinical environment. &nbsp;The individuals in this role take new product concepts and existing medical devices into customer sites to obtain product feedback and clinical experience which includes identifying customer needs, capturing product-related feedback, and evaluating competitive differentiation. &nbsp;The FCSs must objectively translate this feedback to product development and business teams to inform product design decisions and improvements.&nbsp; Responsibilities&nbsp; Clinical Support (70%) • &nbsp; &nbsp;Train, educate and support HCPs on the clinical use of company products• &nbsp; &nbsp;Support clinical sites to complete product evaluations; Provide customer, clinical, and technical support&nbsp;• &nbsp; &nbsp;Obtain and translate customer / clinician feedback to internal teams to inform product design decisions and improvements• &nbsp; &nbsp;Deliver product presentations (one-on-one or group in-services), provide clinical expertise as it relates to product usage in indicated clinical procedures• &nbsp; &nbsp;Establish standards of practice involving company products within clinical and customer sites• &nbsp; &nbsp;Act as clinical liaison between product/business teams and end-user customers• &nbsp; &nbsp;Lead and coordinate lunch &amp; learns, educational events, training symposia and regional conferences as appropriate• &nbsp; &nbsp;Act as a trusted advisor and identify champions, build strong relationships with customers and colleagues• &nbsp; &nbsp;Actively participate in developing training programs and materials related to anatomy, disease states, and products for both internal and external customers• &nbsp; &nbsp;Adhere to company standards and values related to honesty, integrity, trust, respect, and accountability. Perform all responsibilities in accordance with company policies and procedures and applicable state / federal rules and regulations Functional Requirements and General Accountabilities (30%) • &nbsp; &nbsp;Participate in all required training as well as clinical and/or sales meetings, tradeshows, conferences, as needed• &nbsp; &nbsp;Maintain sample inventories, distributing samples in compliance with sample accountability procedures and policies&nbsp;• &nbsp; &nbsp;Provide complete, accurate and timely submission of all documentation to include but not limited to timekeeping, customer interactions - site visit details, customer complaints, call activity logs, expense reports, and consignment and sample tracking• &nbsp; &nbsp;Maintain and update current and prospective customer target profiles • &nbsp; &nbsp;Stay current with market knowledge and competitive products and share knowledge internally• &nbsp; &nbsp;Maintain understanding and full compliance to company compliance programs and policies. Operate within industry guidelines related to AdvaMed, Sunshine Act, and other regulations that provide a framework for appropriate interaction with healthcare professionals• &nbsp; &nbsp;Comply with Promotional Programs, and proper use of Promotional Materials and Promotional Expense Budgets Required Skills and Abilities • &nbsp; &nbsp;Polished professional presence and ability to interact and relate well to physician and nursing community, educators, and other healthcare professionals• &nbsp; &nbsp;Confidence in demonstrating medical devices and discussing procedure-related topics• &nbsp; &nbsp;Ability to successfully give presentations and workshops to medical professionals• &nbsp; &nbsp;Collaborative / Dedicated to teamwork – integrates well with product development, marketing, and sales team.• &nbsp; &nbsp;Comfortable in Cath-lab setting in hospital, ASC and OBL&nbsp;• &nbsp; &nbsp;Organized and responsive to company and customer needs• &nbsp; &nbsp;Self-motivated and directed; ability to take initiative and adapt to fast-changing environment• &nbsp; &nbsp;Masters new technology quickly; strong attention to detail and technical success factors• &nbsp; &nbsp;Strong interpersonal skills and ability to build effective and lasting relationships with customers• &nbsp; &nbsp;Excellent public speaking and communication skills (written and verbal) Minimum Qualifications • &nbsp; &nbsp; Bachelor’s degree required, medical technology, biology, chemistry, or other life sciences preferred• &nbsp; &nbsp;Previous experience in radial access and/or thrombectomy procedures preferred• &nbsp; &nbsp;5-7 years of clinical experience• &nbsp; &nbsp;Experience working with CRM software• &nbsp; &nbsp;Experience partnering with Sales&nbsp;• &nbsp; &nbsp;Willingness to travel (75%) with 2-3 overnight stays a week – throughout region and U.S.• &nbsp; &nbsp;Ability to work a flexible schedule that may change on short notice due to customer needs Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$100,000&mdash;$160,000 USD

Field Clinical Specialist  - MN/SD/ND

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Principal R&amp;D/Product Development Engineer will lead product development activities from concept to commercialization. Principal Responsibilities Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization. Accurately and efficiently translates user and patient needs into verified/validated devices, through creation and refinement of design requirements, design specifications, and test method, and procedures while adhering to design controls best practices. Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements. Owns verification and validation activities through regulatory clearance and design transfer. Manage multiple projects and maintain on-schedule while serving as the primary point of contact for management for those projects. Drives design reviews and ensures on time completion of design control deliverables. Design, assemble and evaluate prototype device assemblies in order to assess technical feasibility of various solutions. May be responsible for direct reports, including reinforcing the open-door policy and ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood. Actively identifies systemic department and organizational improvements as well as product portfolio expansion opportunities; helping to refine our product development strategy and roadmap. Interface with physicians and other medical personnel in a professional manner (maintaining confidentiality and intellectual property vigilance.) Contribute to design/development of product line extensions and product improvements. Author protocols and reports including engineering studies using basic statistical methods. Communicate with outside suppliers for component sourcing and refinement. Develop and own true clinical expertise around clinical/market focus area including: entirety of disease condition relevant anatomical and systemic knowledge medical management, surgical, and interventional treatment options relevant product &amp; procedural treatment options overall clinical risk vs. benefit assessment Minimum Qualifications Bachelor’s degree in engineering or related technical field. 7 years related work experience Ability to apply analytical skills and technical principles to problem solving and product development. Good written and verbal communication skills. Performs work with minimal supervision, in a timely manner. Strong interpersonal and organizational skills and the ability to work effectively as a team member. Familiarity with statistical techniques Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, database, and other applicable software programs. Working knowledge of common lab equipment (caliper, micrometer, tensile tester, pressure tester, vision measurement system) and knowledge of lab practices and techniques). Working knowledge of United States and international standards as applicable to the department. Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$112,500&mdash;$168,600 USD

Principal R&D/Product Development Engineer

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. A Production Operator 2 is expected to manufacture products in accordance with supplied Standard Operating Procedures, adhering to Good Manufacturing Practices, in a clean, controlled environment. Maintaining accurate raw material inventories and adhering to the Quality Policy. Other responsibilities include drafting/revising documentation, training new hires, conducting critical equipment qualification/validation, and supporting projects/new product launch. Responsibilities Production Chemistry (60%) • Manufacture product per SOP as directed by the production planner• Prepare and submit samples to the appropriate QC department• Ensure adherence to GMP guidelines for IVD manufacturing Support Manufacturing (15%) • Transfer and issue consumed raw materials to batches via the MRP system• Maintain thorough, up-to-date production &amp; accounting forms• Review completed batch records for GMP/GDP compliance• Monitor inventory of raw materials• Train production personnel on relevant process and procedures Efficient &amp; Organized Environment (15%) • Monitor inventory of general laboratory supplies• Maintains laboratory equipment and document maintenance activities• Participate in the qualification/validation of new equipment• Oversee the routine housekeeping of the production area, cleaning process equipment, etc.• Keeping equipment on a preventative maintenance schedule Continuous Improvement (10%) • Write or edit standard operating procedures (SOPs) for repetitive manufacturing activities• Work with Quality Assurance to develop SOP’s required as part of the GMP process• Support the resolution of deviations, investigations, non-conformances, and other Quality issues Minimum Qualifications • Bachelor’s degree in a laboratory technology field (i.e. Chemistry, Biology) or 3+ years of production experience as a high level Chemical Operator/Technician (or equivalent)• 2+ years’ experience as Chemical Operator/Technician• Organizational and documentation skills and general problem solving ability• Good interpersonal skills and an ability to provide effective work direction• Excellent written and verbal communication skills• Computer skills appropriate for work responsibilities Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$47,300&mdash;$66,200 USD

Production Operator 2

Title:&nbsp;Quality Engineer Report To: Staff Quality Engineer Location: Ballinasloe, Co. Galway Permanent Role Onsite Role, Days of Work: Monday to Thursday (4 Day Work Week) Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical devices and diagnostic solutions. Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. &nbsp; &nbsp;Job Summary The Quality Engineer is a key member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System on site. &nbsp;Responsibilities&nbsp; Partner with R&amp;D and Process Engineers to ensure that the transition of products through R&amp;D and sister sites, product approval and manufacturing scale up are smooth, timely and cost effective. Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards. Participates in new product/technology development and supports the QA activities as part of an overall project team. Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes. Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings. Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met. Continually seeks to drive improvements in product and process quality. Develops and executes required validations in line with regulatory standards to include equipment, process and product validations. Conducts root cause analysis and implements corrective action in a timely manner. Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action. Creates and maintains company quality documentation. Deals with suppliers and ensures their quality standards are in line with company standards. Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required. Provides manufacturing line support and provide Quality expertise in relation to Manufacturing issues and product disposition. Education and Qualifications An Engineering or Quality Assurance Degree or equivalent experience. A minimum of 3 years post qualification experience as a Quality Assurance Engineer within a Medical Device or regulated environment. Competencies and Attributes Demonstrable detailed working knowledge of the medical device industry. An analytical approach to problem solving. Is creative, continually learning and exploring new ideas. A self starter that applies their own initiative in most situations. A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments. A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation. Capacity to make sound judgements while learning from mistakes. Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements. Attention to detail while maintaining awareness of longer-term objectives. Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda. Displays the highest levels of integrity. Capacity to maintain the highest levels of confidentiality internally and externally. Ability to stay connected to multiple projects simultaneously. &nbsp; &nbsp; What Surmodics offers We offer competitive rewards &amp; compensation package to meet the needs of our employees, and this includes:&nbsp; Competitive Salary Package 4 day working week Medical Insurance Defined Contribution Pension with employer match Bonus program Life assurance cover Recognition Awards&nbsp; Career advancement opportunities Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities. &nbsp;

Quality Engineer

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Quality Engineer 2 is a key team member in supporting medical device manufacturing through commercial distribution. &nbsp;They will maintain oversight of all manufacturing activities and be responsible for the final release of sterile medical devices. &nbsp;Key partnerships with Operations, Marketing, Complaints, Supply Chain, Engineering, and other functional experts will be developed as needed to ensure a consistent flow of product to meet customers’ needs and to address actions for field inventory as necessary. &nbsp; They will look to continuously improve internal processes to drive efficiency in the day-to-day activities. &nbsp; Responsibilities &nbsp; Commercial production requires consistent support to ensure product is safe and effective for patients. The Sr. Quality Engineer supports operations by: &nbsp; Support materials receiving and inspection activities with Supplier Quality as owner &nbsp; Ensure quality of produced products by understanding production process and performing/reviewing in-process and finished goods inspections &nbsp; Review sterilization results for sterile product and addressing any non-conformances, release sterile product&nbsp; Draft and route a variety of protocols and reports for product, processes, manufacturing events, and equipment changes/activities &nbsp; Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) &nbsp; Support controlled facilities environment by participating in environmental monitoring, calibration, and preventive maintenance activities &nbsp; Perform equipment qualification for any new and changing equipment requirements &nbsp; Initiate/support quality system changes that drive consistency and efficiency &nbsp; Generate and evaluate metrics that are used to identify negative trends and areas for improvement &nbsp; Maintain oversight of commercial product to ensure safety and traceability &nbsp; Manage any returned product through inspection and disposition &nbsp; Assist in field return investigation and the coordination of any necessary field action/market withdraw &nbsp; May be assigned other responsibilities of the company's quality system. &nbsp; Minimum Qualifications&nbsp; BS or advanced degree in technical discipline &nbsp; 5+ years overall medical device experience &nbsp; 5+ years’ experience in quality assurance or engineering function &nbsp; 3+ years support of a medical device in a quality engineering function &nbsp; Understanding of Quality Systems requirements as outlined in CFR820/ ISO13485, and be able to communicate true requirements to cross-functional teams &nbsp; Knowledge of medical device design control waterfall &nbsp; Experience with utilizing a risk-based approach to quality systems processes &nbsp; Demonstrated technical expertise and leadership in quality &nbsp; Strong ability to communicate (written and verbally) within and across disciplines and organizational structures &nbsp; Strong emotional intelligence to work effectively in a fast-paced, highly-collaborative environment &nbsp; Self-starter, with the ability to manage multiple tasks and tight timelines &nbsp; Demonstrated use of Quality tools and methodologies &nbsp; High attention to detail, organization, and accuracy &nbsp; Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$78,400&mdash;$117,600 USD

Quality Engineer 2

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Regional Sales Manager is responsible for building and leading a regional sales team, meeting, or exceeding regional business objectives via quarterly assigned milestone goals for hiring/team development, revenue achievement and product introductions. The Regional Sales Manager and team will be responsible for promoting the vascular intervention product line externally and for translating and communicating customer feedback back to Surmodics (SRDX). &nbsp;In addition, the Regional Sales Manager is responsible for customer relationships (both physician and administrative) in a compliant manner within Surmodics business practices. Responsibilities&nbsp; Recruit, lead and manage team of field sales personnel• &nbsp; &nbsp;Recruit and hire field personnel within assigned regional geography (and assist VP outside of assigned geography) in partnership with human resources• &nbsp; &nbsp;Coach and manage team members to meet and exceed sales targets. &nbsp;Manage performance to assisgned company goals and intiatives.• &nbsp; &nbsp;Ensure team acts in compliance with all laws and company rules and regulations&nbsp; Customer Development and Revenue Generation• &nbsp; &nbsp;Utilize available data to create and execute effective business plans with team to meet and achieve sales objectives (revenue, product launches, etc.)• &nbsp; &nbsp;Guide your team to strategically and effectively launch multiple new products/product lines across geography• &nbsp; &nbsp;Develop customer champions who can support Surmodics’ growth efforts Account management and new business development&nbsp;• &nbsp; &nbsp;Strengthen relationship/partnership with existing accounts while building strong relationship with new customers• &nbsp; &nbsp;Develop strategic plans tailored for each business relationship. The plan should identify the SRDX actions and support needed in execution• &nbsp; &nbsp;Maintain ongoing communication with SRDX team members and Executive Management regarding account progress• &nbsp; &nbsp;Responsible for quarterly/annual forecasting of regional revenues and execution to exceed revenue goals.• &nbsp; &nbsp;Conduct quarterly field visits and provide feedback for development.• &nbsp; &nbsp;Conduct quarterly business review of each individual territory&nbsp;• &nbsp; &nbsp;Create quarterly business plan for your region for VP of Sales Minimum Qualifications • &nbsp; &nbsp;B.S. or B.A. degree, preferably in business, engineering or science-related field• &nbsp; &nbsp;10+ years experience in sales/sales management (minimum of 5 years in medical device sales), business development, marketing or related business-to-business partnering; cardiovascular experience preferred• &nbsp; &nbsp;Advanced written and verbal communication skills, strong interpersonal skills• &nbsp; &nbsp;Computer skills appropriate for work responsibilities, including CRM software experience• &nbsp; &nbsp;Willingness to travel (75%), flexibility to accommodate a schedule that changes on short notice due to customer needs Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$140,700&mdash;$211,000 USD

Regional Sales Manager - Midwest

Senior Field Clinical Specialist  - Las Vegas Area

Senior Field Clinical Specialist  - Louisiana/Arkansas Area

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Senior Sustaining Engineer position is responsible for maintaining existing commercialized products post transfer by ensuring the products remain safe, compliant and optimized for manufacturing process performance. &nbsp;In addition, the position provides quality engineering support for all phases of the product lifecycle at Surmodics. &nbsp;This position is critical in driving continuous improvements to existing products to ensure they meet or exceed internal and external requirements. The ability to assess business and customer needs and risks in a fluid environment is essential for this role.&nbsp; Responsibilities&nbsp;Product Development (approx. 20-30%)• &nbsp; &nbsp;Provide technical expertise in design controls and risk management• &nbsp; &nbsp;Develop risk management plans and lead cross-functional risk management activities• &nbsp; &nbsp;Draft documents and provide technical review for document revision, review and approval• &nbsp; &nbsp;Maintain design history file and lead design review discussions• &nbsp; &nbsp;Support design transfer activities including new equipment qualification&nbsp; Purchasing &amp; Supplier Controls (&lt; 5%)• &nbsp; &nbsp;Support the investigation and resolution of issues related to supplied raw materials and services• &nbsp; &nbsp;Lead efforts to assess and qualify new or changed supplied raw materials Continuation Engineering (approx. 70-80%)• &nbsp; &nbsp;Drive / support engineering activities for design and/or process changes to existing products by troubleshooting identified issues using good engineering practices, developing evidence-based project plans, and executing on deliverables• &nbsp; &nbsp;Implement opportunities to optimize/improve manufacturing processes and systems• &nbsp; &nbsp;Ensure strong cross-functional collaboration, timely multi-disciplinary input and compliance with regulatory standards and internal quality system requirements• &nbsp; &nbsp;Lead cross-functional activities for completion of risk management deliverables when changes are required; Perform risk management assessment for changes• &nbsp; &nbsp;Analyze and execute engineering change control efforts per established processes and manage the deliverables per QMS requirements• &nbsp; &nbsp;Analyze customer change notification requirements to support internal process changes• &nbsp; &nbsp;Lead discussions with customers to address quality issues and change notifications• &nbsp; &nbsp;Support product stability programs by reviewing protocols and reports&nbsp;• &nbsp; &nbsp;Perform root cause investigations, propose corrective actions and oversee their implementation by using problem solving tools• &nbsp; &nbsp;Support complaint investigation efforts as needed, including returned product evaluation.• &nbsp; &nbsp;Develop and maintain key quality metrics Validation (&lt; 5%)&nbsp;• &nbsp; &nbsp;Provide technical support to project teams• &nbsp; &nbsp;Draft and approve protocols and reports Minimum Qualifications• &nbsp; &nbsp;Four-year technical degree with minimum 5 years’ experience in a Quality Engineering role or similar• &nbsp; &nbsp;ASQ Quality Engineering certification desired• &nbsp; &nbsp;Experience and training in process and equipment validation&nbsp;• &nbsp; &nbsp;Extensive experience with QSR and ISO quality systems• &nbsp; &nbsp;Extensive experience with statistical techniques, measurement/trending and SPC tools• &nbsp; &nbsp;Strong attention to detail• &nbsp; &nbsp;Proficient computer skills- Microsoft Word, Access and Excel, statistical software (JMP, MINITAB)• &nbsp; &nbsp;Excellent analytical and problem-solving skills• &nbsp; &nbsp;Ability to read and follow detailed instructions including generating detailed instructions• &nbsp; &nbsp;Excellent written and verbal communication skills• &nbsp; &nbsp;Excellent interpersonal skills• &nbsp; &nbsp;Ability to prioritize activities relative to competing demands from multiple sources Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.Targeted Salary Range$88,500&mdash;$132,600 USD

Senior Sustaining Engineer

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. The Territory Manager is responsible for managing a sales territory, meeting or exceeding business objectives via yearly (or more frequent) assigned milestone goals for revenue achievement and product introductions. The Territory Manager will be responsible for promoting the vascular intervention product line externally and for translating and communicating customer feedback back to Surmodics via appropriate channels. Responsibilities Customer Development and Revenue Generation Create an execute effective business plans to meet and achieve sales objectives (revenue, product launches, etc.) Strategically and effectively launch multiple new products/product lines across geography Strengthen relationship/partnership with existing accounts while building strong relationship with new customers Account management and new business development Train customers and support cases to ensure appropriate use of SRDX products Maintain appropriate tracking of SRDX products, to include consignment and rep stock inventory Complete all required training and maintain required documentation (customer complaints, vendor credentialing, etc.) Responsible for quarterly/annual forecasting of regional revenues Act in compliance with all laws and company rules and regulations Minimum Qualifications B.S. or B.A. degree, preferably in business, engineering or science-related field and/or healthcare degree or certification (i.e. nursing or technologist background) 5+ years experience in medical device sales/clinical support, training, marketing or related clinical experience; cardiovascular experience preferred Strong written and verbal communication, interpersonal skills Computer skills appropriate for work responsibilities, including CRM software experience Willingness to travel (up to 75%, dependent on territory), flexibility to accommodate a schedule that changes on short notice due to customer needs Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.&nbsp;&nbsp; Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program. Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. &nbsp;Targeted Salary Range$99,500&mdash;$149,200 USD

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