Project Lead, Combination Product Engineering

Job Description

About This Role

As the Project Lead for Combination Product Engineering, you will join the Devices and Packaging Development team, specifically within the Medical Device group. Reporting to the Head of Human Factors & Device Strategic Operations, you will play a critical role in sustaining engineering strategies and processes, ensuring that commercial devices and combination products remain updated, compliant, and cost effective throughout their lifecycle, with no interruption to commercial supplies. 

What You’ll Do

• Work across disciplines to plan, influence, and implement sustaining engineering strategies and processes; liaise with asset teams to ensure sustaining engineering is integrated in commercial asset plans
• Partner with cross-functional teams to address vendor change notifications and manage the impact of changes to commercial medical devices, (development design history files, manufacturing processes and control strategies).
• Liaise with internal stakeholders across PO&T to prioritize resources and budget allocation, anticipate business needs and develop forward looking plans to ensure commercial supply continuity.
• Engage with external partners for on-time execution of development and manufacturing activities 
• Be a representative of the device development group at relevant forums to inform decisions and strategies
• Shape regulatory strategies and approve relevant compliant report, change controls and compliant documents

Who You Are

You have experience in medical device design and development. You have a deep understanding of lifecycle management of medical devices, including knowledge of regulatory and compliance requirements. Your strong communication, collaboration, and team building skills make you able to quickly to connect with all levels of the organization.

Qualifications

Required Skills

• Bachelor’s Degree in Engineering
• 7+ years’ experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly
• 2+ years’ experience developing multiple device and combination product device products from research through registration and launch
• Understanding of new product introduction, design, and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies.
• Knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e., FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 11608, and other relevant global standards).

Preferred Qualifications: 

• Master’s Degree or MBA in mechanical or related engineering
• Proven track record of developing and gaining regulatory approval of drug delivery systems. #LI-CC1

Additional Information

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 our DE&I efforts.

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.