About the position
This position delivers engineering solutions to sustain production of implantable and consumable medical devices. Responsibilities include working with cross-functional teams to support design and supplier changes, CAPAs, NCRs, Product Complaints and other compliance projects. This job requires knowledge of medical device regulations including design controls.
Responsibilities
- Initiates design change projects to improve product performance, reduce cost and enhance the manufacturability of commercially released medical devices.
- Works with current suppliers on changes to existing purchased components and with new prospective suppliers.
- Supports CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
- Participates in Design Reviews to evaluate adequacy of design requirements, assess the capability of the design to meet requirements and identify and resolve problems.
- Works cross-functionally on design changes, process improvement projects and quality/compliance initiatives.
- Creates and executes protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
- Aids in the selection, design and evaluation of process and test equipment.
- Creates and executes protocols and reports for process validation, test method validation, equipment qualification and gage R&R studies.
- Processes change orders to create or revise design input and output documentation.
- Performs product testing and engineering studies to support design change and investigational activities.
- Performs Out of Specification (OOS) investigation reports for test failures.
- Supports Out of Tolerance (OOT) investigations for equipment calibration failures.
- Supports the development and revision of part specifications and other design documentation.
- Maintains the Design History File (DHF) and Device Master Record (DMR) throughout the lifecycle of the product based on changes to the product design or manufacturing process.
- Periodically provides updates to project teams and program managers.
- Contributes to the team effort by accomplishing related tasks as needed.
Requirements
- Bachelor’s degree in Engineering or scientific discipline, such as chemical, biomedical, materials, or mechanical engineering.
- A minimum of two years’ experience in the medical device industry (or other regulated industry) with relevant experience in design controls, production and process controls and/or R&D or related areas.
- Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
- Strong experience with Microsoft Office applications (Word/Excel/PowerPoint) is required.
Nice-to-haves
- Experience with Agile PLM and Minitab desired.
- Knowledge of Good Documentation Practices (GDP) required.
- Excellent verbal and written communication skills.
Benefits
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
