Project Lead, Combination Product Engineering
4 weeks ago
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.
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Cambridge, United States Biogen Full timeJob 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...
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Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout 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...
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Cambridge, United States Biogen Full timeJob DescriptionJob DescriptionJob DescriptionAbout 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...
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