Design Control & Risk Management Lead

One of our large pharmaceutical clients is actively hiring a Design Control and Risk Management lead, supporting the Combination Product, Device Development Team. This project is focusing on autoinjectors and they will be
responsible for leading and implementing Medical Device & Combination Product Design Control & Risk Management activities for new products from early design concept, clinical and through commercialization. This position will interact with cross-functional development teams and within Device Development. This resource must be able to work well with all levels of employees and be able to effectively coordinate the execution of autoinjector device development strategies.

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

This is a hybrid role, 3 days onsite, 2 WFH.

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Required Skills & Experience

10 years' experience in Combination Product
Experience working on an Autoinjector, or on-body device
Design Control & Risk Management experience
Lead and authoring of design control & risk management deliverables
B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering or other types of engineering.

Nice to Have Skills & Experience

Regulatory Intelligence

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.