Senior Principal Combination Product Quality Engineer (Associate Director)

Job Description

Biogen is seeking a seasoned Senior Principal Combination Product Quality Engineer to serve as an Associate Director within our Quality, Combination Products, and Devices team. In this role, you will provide comprehensive quality oversight for the lifecycle management of combination products. Your expertise in design control, risk management, and human factor engineering will drive continuous improvement efforts and ensure compliance with local and global regulations. You will play a critical role in shaping our design and development processes, contributing to regulatory strategies, and managing external partnerships.  

What You’ll Do: 

• Provide Subject Matter Expertise in combination products, guiding quality engineering function on related issues. 

• Lead the execution of Design Control processes across all stages of product development. 

• Ensure compliance with global quality standards by reviewing and approving technical documentation. 

• Guide R&D and manufacturing design processes to implement effective Design Control principles. 

• Manage external relationships with device suppliers and testing partners, ensuring adherence to quality standards. 

• Spearhead continuous improvement initiatives within the device and combination product Quality Management System (QMS). 

• Support regulatory filings and audits, acting as the final Quality approval authority for device sections. 

• Participate in internal and external audits and facilitate regulatory inspections. 

Who You Are: You are a forward-thinking R&D engineer with a keen interest in end-to-end quality engineering and risk management with recognized expertise in executing within medical device, biopharmaceutical and combination products sectors. Your innovative approach and statistical acumen make you natural at navigating the complexities of device quality in the biotechnology field. You possess a passion to optimize Quality Management Systems (QMS) from a compliance function to a proactive business enabler tool to address patients’ unmet needs. You are a recognized SME with execution record in end-to-end Design Control, Risk Management, Post Market Surveillance, and Human Factor Engineering for complex combination products.  #LI-CC1

Qualifications

Required Skills: 

• Master's Degree in Engineering  

• Minimum 8 years' experience in Combination Product R&D or Device Quality Engineering within the Pharmaceutical/Biotech industries. 

• Demonstrated experience in the end-to-end commercial launch/validation of a Combination Product or Medical devices

• Strong grasp of Risk Management for combination products and medical devices. 

• Proficient understanding of Design Controls, cGMP, ISO 13485, QSR (21 CFR Part 820), and ISO 14971. 

• Proven track record in verification & validation plans and user needs translation. 

• Familiar with statistical tools and validation/verification techniques. 

• Demonstrated ability in regulatory filings and inspection facilitation. 

• Experience in matrix organization and exceptional communication skills. 

• Strong project management, negotiation, and interpersonal skills. 

Preferred Skills: 

• PhD with 4+ years of experience in Combination Product R&D within the Pharmaceutical/Biotech industries 

• Experience with Class III medical devices. 

• Quality certifications (e.g., CQE, Six Sigma). 

• 1+ years of people management experience. 

Additional Information

The base compensation range for this role is $143k - 208k. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

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, a