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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 a key position that will be responsible for maintaining existing commercialized Vascular Interventions (VI) products post transfer by ensuring the products remains safe, complaint and optimized for manufacturing process performance. The role is critical in driving continuous improvements to existing products to ensure they meet or exceed internal and external requirements. Experience working with R&D/Development is required.
Responsibilities
- Drive engineering activities for design and/or process changes to existing products by developing evidence-based project plans and executing on deliverables.
- Ensure strong cross-functional collaboration, timely multi-disciplinary input and compliance with regulatory standards and internal quality system requirements.
- Standardize and drive the forum to gather, prioritize, and estimate effort for sustaining activities across product lines with cross-functional teams.
- Leads design verification, design validation, usability and test method validations activities for design changes to meet or exceed internal and external requirements.
- Develop, drive execution, and implement design inputs and design outputs for changes to existing products. Develop new test methods and/or revise existing test methods to support the changes. Execute or lead execution on test method validations.
- Cross-functional leader for completion of Risk Management deliverables when changes are required. Perform risk management assessment for changes.
- Collaborate and oversee both product and process changes at Contract Manufacturing Organizations (CMO) as part of a Surmodics core support team
- Manage Quality System processes necessary to properly document and assess sustaining activities.
- Perform root cause investigations, propose corrective actions and oversee their implementation by using problem solving tools.
- Support complaint investigation effort as needed, including returned product evaluation, testing, and health risk assessment.
- Support regulatory approvals and responses to regulatory agencies’ questions.
- Accountable for the implementation of opportunities to optimize/improve manufacturing processes and systems.
- Execute engineering change control efforts per established processes and manage the deliverables per QMS requirements.
- Coordinate design/process change implementation into production.
- Other activities as assigned
Minimum Qualifications
- BS or advanced degree in engineering or related discipline
- 5+ years medical device experience in engineering function
- Expert knowledge of Design Control and Risk Management
- Knowledge of problem-solving methodologies and approaches
- Experience with Quality Systems as outlined in CFR820/ ISO13485
- Experience leading CAPA investigations and developing effective corrective actions that utilize a risk-based approach
- Excellent facilitation and presentation skills
- Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
- Ability to manage competing priorities in a fast-paced environment
- Demonstrated use of Quality tools and methodologies
- Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.) High attention to detail, organization, and accuracy
- Ability to plan and implement technical tasks that may not be well-defined, have multiple variables and require advanced implementation techniques
Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.
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.
