Senior Engineer/Manager, Device Development — Combination Products

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Role: Senior Engineer/Manager, Device Development - Combination Products

leading technical execution and program management for autoinjectors, prefilled syringes, or wearable injectors within biopharma drug development pipelines.

Responsibilities

overseeing device design control documentation, supporting human factors/usability engineering activities, standardizing platform components, and managing external supplier relationships and technology transfers. The role also involves providing manufacturing support during clinical and commercial phases, ensuring quality and compliance, and collaborating with cross-functional teams (Regulatory, Quality, CMC, Clinical).

Qualifications

BS/MS in Mechanical, Biomedical Engineering
5-7 years’ experience in device development, especially for combination products like autoinjectors or prefilled syringes
expertise in design controls, ISO standards, FDA regulations, and 3D modeling (SolidWorks)

Preferred

experience with human factors studies, program lifecycle management, and biologic injectables
prior manufacturing site support

HighValue

biologics, combination devices, clinical and commercial manufacturing, regulatory documentation, cross-functional collaboration, international travel (~20-30%).

WorkSetup

Hybrid Waltham, MA with travel.

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Vacancy posted 1 day ago

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