Senior Design/Manufacturing Engineer

Job title: Senior Design/Manufacturing Engineer

About the Role The role delivers engineering 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, applying knowledge of medical device regulations including design controls.

What You'll Do

• Leads design change projects to improve product performance, reduce cost and enhance manufacturability of commercially released medical devices.
• Leads CAPAs, NCRs and Product Complaints by investigating and addressing potential product design issues as appropriate.
• Leads 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.
• 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.
• 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.
• Successfully leads project teams by identifying and mitigating project risks and tracking all project deliverables to completion.
• Mentors junior-level staff and provides updates to management on project status.
• Supports internal and external audits.
• May require 5-10% travel and may work extended hours during peak cycles.

What We're Looking For

• Bachelor's degree in Engineering or scientific discipline (chemical, biomedical, materials, or mechanical).
• Minimum five years' experience in the medical device industry (or other regulated industry) with knowledge of design controls, production/process controls and/or R&D.
• Experience leading cross-functional project teams and making decisions.
• Knowledge of 21 CFR Part 820 and standards relevant to medical devices.
• Proficiency with Microsoft Office (Word/Excel/PowerPoint).
• Demonstrated ability to solve technical challenges with cross-functional teams; strong analytical and problem-solving skills; excellent verbal and written communication.
• Self-motivated with the ability to accomplish project goals with minimal supervision.
• Experience with Agile PLM and Minitab desired.
• Knowledge of Good Documentation Practices (GDP).

Nice to Have

• Agile PLM and Minitab experience.

Compensation & Benefits

• Salary: $95,000 - $120,000 per year, plus 10% STIP.
• Benefits: Health, Dental, and Vision insurance; 401k with company match; Paid Time Off; Wellness initiative & Health Assistance Resources; Life Insurance; Short and Long Term Disability Benefits; Flexible Spending Accounts; Commuter Benefits; Parental and Caregiver Leave; Tuition Reimbursement.