Senior Device Quality Engineering Lead
$138,000–$185,000 year
Hybrid · Cambridge, Massachusetts, United States or Research Triangle Park, North Carolina, United States
Job Summary
Lead quality engineering guidance and oversight for medical devices and combination products across feasibility, design control, risk management, and lifecycle management. Define critical quality characteristics for device components and finished devices in collaboration with the device development team. Support audits as a device or combination product Subject Matter Expert. Oversee the quality review and approval of technical documentation, ensuring compliance with regulatory requirements. Provide input to process manufacturing design and design transfer for robust product realization. Support asset team strategies for regulatory filings, design control, and risk management. Lead continuous improvement initiatives for the Quality Management System and lifecycle processes. Function as the quality representative on cross-functional initiatives and device development programs. Manage quality assurance interfaces with medical device suppliers and testing partners in collaboration with External Quality.
Required Qualifications
- BS in Biomedical/Mechanical Engineering or related technical or scientific discipline
- At least 7 years of experience in medical device and/or combination product industries
- Extensive knowledge of design control and risk management for medical devices
- Strong understanding of regulatory requirements and quality standards
- Excellent communication and collaboration skills
- Proven ability to lead cross-functional teams and initiatives
- Experience in leading continuous improvement initiatives within a Quality Management System
- Familiarity with medical device supplier and testing partner management
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