Senior 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

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.

Job Level

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.

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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

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.

As Biogen recently acquired Apellis, you can find additional open jobs on our Apellis website here.

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.