Senior Device Quality Engineering Lead

Biogen

Senior Device Quality Engineering Lead at Biogen overseeing quality for medical devices and combination products. Collaborating with development teams and driving compliance throughout the device lifecycle.

Posted 6/11/2026full-timeCambridge • Massachusetts, North Carolina • 🇺🇸 United StatesSenior💰 $138,000 - $185,000 per yearWebsite

About the role

Key responsibilities & impact

Lead quality engineering guidance and oversight for medical devices and combination products during 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 internal and external 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.

Requirements

What you’ll need

Minimum of a 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.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality engineeringdesign controlrisk managementquality management systemtechnical documentationregulatory complianceprocess manufacturing designcontinuous improvementmedical device developmentcombination products

Soft Skills

communicationcollaborationleadershipcross-functional team managementinitiative management

Certifications

BS in Biomedical EngineeringBS in Mechanical Engineering