Senior Device Quality Engineering Lead

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

About This Role

As the Senior Device Quality Engineering Lead, you will hold a pivotal role in ensuring the quality oversight of design control and risk management activities for combination products and medical devices. This senior-level position requires you to work closely with device development teams, medical device suppliers, and testing partners during the design and development phases, extending your support throughout the device lifecycle. Your expertise will drive the development, implementation, and continuous improvement of device-related quality processes and procedures, ensuring compliance with relevant standards and regulatory requirements. By providing strategic guidance and oversight, your role will be integral to the product quality and integrity across all modalities within the organization.

This is a hybrid role that can be located either in Research Triangle Park, NC or Cambridge, MA.

What You’ll Do

• 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.

Who You Are

You are a detail-oriented and dedicated professional with a passion for quality assurance in the medical device industry. Your analytical mindset allows you to identify areas for improvement and implement effective solutions. You thrive in collaborative environments and are skilled at building strong relationships with internal teams and external partners. Your commitment to regulatory compliance and product quality ensures that you consistently deliver high standards. You have a proactive approach to problem‑solving and a continuous improvement mindset that drives you to seek innovative solutions.

Required Skills

• 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.

Additional Information

The base compensation range for this role is: $138,000.00-$185,000.00.

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long‑term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Job Level: Management.

Benefits

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well‑being; including, but not limited to:

• 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

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E‑Verify Employer in the United States.