Senior Hybrid Medical Device Quality Engineering Lead

Biogen, Inc.; Cambridge (MA); Hybrid; USD 138,000 - 185,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness reimbursement

Paid vacation and holidays

Parental leave

401(k) matched contributions

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking a Senior Device Quality Engineering Lead to oversee design control and risk management for medical devices and combination products. This hybrid role can be based in Cambridge, MA or RTP, NC, supporting lifecycle quality, audits, and regulatory compliance.

You will guide device development teams, manage supplier interfaces, and drive continuous improvement of the Quality Management System to ensure product integrity across modalities.

Qualifications

• BS in Biomedical/Mechanical Engineering or related technical discipline.
• 7+ years in medical device 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 leading continuous improvement within a Quality Management System.
• Familiarity with medical device supplier and testing partner management.

Responsibilities

• Lead quality engineering guidance and oversight for devices and combination products across feasibility, design control, risk management, and lifecycle.
• Define critical quality characteristics for device components and finished devices with the development team.
• Support audits as a device/CP SME (internal and external).
• Oversee quality review and approval of technical documentation for regulatory compliance.
• Contribute input to design transfer for robust product realization.
• Support asset team strategies for regulatory filings, design control, and risk management.
• Lead CI initiatives within the Quality Management System and lifecycle processes.
• Act as the quality representative on cross-functional device development programs.
• Manage QA interfaces with suppliers and testing partners with External Quality.

Skills

Quality engineering

Regulatory knowledge

Cross-functional leadership

Supplier management

Communication skills

Continuous improvement

Design controls

Audits readiness

Education

BS in Biomedical/Mechanical Engineering or related

Job description

Biogen is seeking a Senior Device Quality Engineering Lead to oversee design control and risk management for medical devices and combination products. This hybrid role can be based in Cambridge, MA or RTP, NC, supporting lifecycle quality, audits, and regulatory compliance.

You will guide device development teams, manage supplier interfaces, and drive continuous improvement of the Quality Management System to ensure product integrity across modalities.