Design Control & Risk Management Lead for Combination Products

One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management Engineer on the Combination Product Team, specializing in a unique drug delivery product. This team supports new product development, commercialization and life-cycle management activities of medical device and combination products. They will be responsible for supporting projects surrounding a specialized drug delivery method and the strategy to support clinical studies/commercialization. You would be heavily involved in leading meetings to define requirements, risk, and support development for ocular and auto-injector programs. You will be working with cross-functional partners on deliverables required to get the project to major clinical studies.

Responsibilities:
- Lead the creation of Device Development, Design Control and Risk Management deliverables for the assigned projects.
- Lead the implementation and/or ensures effective execution of the Device Development Strategy, Design Control and Risk Management activities for the assigned projects.
- Proactively resolve project obstacles and challenges
- Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
- Lead conversations with external suppliers

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Required Skills & Experience

10 years' experience in Medical Device
Combination Product/Drug Delivery experience, specifically with Auto Injectors
Design Control & Risk Management experience
B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.