Senior Engineer - Onsite Role

About the Role This onsite engineering role focuses on delivering solutions to sustain production of implantable and consumable medical devices. You will lead cross-functional teams to support design and supplier changes, CAPAs, NCRs, product complaints, and other compliance projects, requiring knowledge of medical device regulations and design controls. What You'll Do

• Lead design change projects to improve product performance, reduce cost and enhance manufacturability of commercially released medical devices.
• Lead CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
• Lead Design Reviews at appropriate stages to evaluate adequacy of design requirements, assess the capability of the design to meet requirements and identify and resolve problems.
• Work cross-functionally on design changes, process improvement projects and quality/compliance initiatives.
• Create and execute protocols for Design Verification and Validation activities, engineering studies and feasibility studies.
• Aid in the selection, design and evaluation of process and test equipment.
• Create 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.
• Perform product testing and engineering studies to support design change and investigational activities.
• Perform Out of Specification (OOS) investigation reports for test failures.
• Support Out of Tolerance (OOT) investigations for equipment calibration failures.
• Support the development and revision of part specifications and other design documentation.
• Maintain 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.
• Successfully lead project teams by identifying and mitigating project risks and tracking all project deliverables to completion.
• Provide technical expertise throughout the supplier selection and evaluation process.
• Mentor junior-level staff members.
• Provide updates to management on project status.
• Support internal and external audits.
• Contribute to the team effort by accomplishing related tasks as needed. What We're Looking For
• Bachelor’s degree in Engineering or scientific discipline.
• Knowledge of medical device regulations including design controls.
• Demonstrated ability to lead cross-functional teams and manage design changes in a regulated environment. Nice to Have Compensation & Benefits
• Salary range: $95,000 - $120,000 per year
• 10% Short-Term Incentive (STIP)
• Hybrid remote work arrangement (1-2 days at home) as part of onsite role