Hybrid Senior Device Quality Lead – MedTech Quality & Lifecycle

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

Benefits offered by this job

Medical, Dental, Vision insurance

Fitness & Wellness programs

Long-Term Disability insurance

Paid maternity and parental leave

401(k) with company match

Tuition reimbursement

Job summary

Biogen is seeking a Senior Device Quality Engineering Lead in Cambridge, MA to ensure quality oversight of design control and risk management for medical devices. This hybrid role involves collaboration with device development teams, enforcing quality processes, and compliance with regulatory standards.

A BS in Biomedical/Mechanical Engineering and at least 7 years of experience in the medical device field are required. The position offers competitive compensation and comprehensive benefits.

Qualifications

• 7+ years of experience in medical device and/or combination products.
• Extensive knowledge of design control and risk management.
• Strong understanding of regulatory requirements and quality standards.

Responsibilities

• Lead quality oversight for medical devices during their lifecycle.
• Define critical quality characteristics in collaboration with development teams.
• Support audits as a Subject Matter Expert.

Skills

Attention to detail

Analytical mindset

Excellent communication

Leadership of cross-functional teams

Education

BS in Biomedical/Mechanical Engineering or related discipline

Job description

Biogen is seeking a Senior Device Quality Engineering Lead in Cambridge, MA to ensure quality oversight of design control and risk management for medical devices. This hybrid role involves collaboration with device development teams, enforcing quality processes, and compliance with regulatory standards.

A BS in Biomedical/Mechanical Engineering and at least 7 years of experience in the medical device field are required. The position offers competitive compensation and comprehensive benefits.