Project Lead, Combination Product Engineering

Job Description

The Devices and Packaging Development team is looking for a Senior Engineer as an important role within the Medical Device group. Sustaining Engineering plays a critical role in ensuring commercial supply continuity. The responsibility of this function is primarily to ensure that commercial devices and combination products, once launched, remain updated, compliant and cost effective through their lifetime which can exceed 10 years with no interruption to commercial supplies.  The responsibility spans across all modalities in Biogen portfolio of commercial devices.

This Project Lead has the following responsibilities: will 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; engage with and effectively influence external partners to ensure Biogen’s needs are addressed; ensure timely completion of activities associated with vendor change notifications; address users complaints as relevant. Expertise in Medical Device development, creating collaborative environment, project management skills, tactical agility and focus on execution will also be key priorities. 

This is a hybrid role that will be based at our headquarters in Cambridge, MA. 

What You’ll Do

• Partner with cross-functional teams to address vendor change notifications and manage impact of changes to commercial medical devices, to development design history files, to manufacturing processes and to 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.
• Liaise with external partners to ensure on-time execution of development and manufacturing activities for commercial assets.
• Be a representative of the device development group at relevant forums to inform decisions and strategies (annual business review meetings, virtual plant team meetings, asset teams’ meetings ...)
• Inform regulatory strategies, author / review / approve annual complaints report, change controls and relevant compliant documents.

Qualifications

Who You Are

You have experience working in cross-functional teams performing high impact work in high pressure environment. You should have experience in medical device design, development, and softwares as medical devices (SaMDs). You should have a deep understanding of lifecycle management of medical devices including knowledge of the regulatory and compliance requirements, strong communication, collaboration and team building skills; ability to connect with all levels of the organization. You should be comfortable working in a matrix environment, while embracing and driving change.

Required Skills

• Bachelor’s Degree in Engineering
• 7-10 years’ experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly.
• 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).
• Experience developing multiple device and combination product device products from research through registration and launch.

Preferred Qualifications: 

• Master’s Degree or MBA in mechanical or related engineering discipline with 8+ years’ experience.
• Proven track record of developing and gaining regulatory approval of drug delivery systems.

Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

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.