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 teamsto ensure sustaining engineering is integrated in commercial asset plans
Partner with cross-functionalteams 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.