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About the Role
Job Description:
Senior Product Development Engineer to support the design and development of drug-device and biologic-device combination products for a fast-growing biotechnology company. The role focuses on drug delivery systems, design controls, and end-to-end product lifecycle support in a regulated environment. This is an onsite role based in the Boston, MA or Providence, RI area.
Responsibilities:
Senior Product Development Engineer to support the design and development of drug-device and biologic-device combination products for a fast-growing biotechnology company. The role focuses on drug delivery systems, design controls, and end-to-end product lifecycle support in a regulated environment. This is an onsite role based in the Boston, MA or Providence, RI area.
Responsibilities:
- Author and maintain design control documentation, including Design History Files (DHF).
- Ensure compliance with FDA, EU MDR, ISO standards, and internal quality systems.
- Support product development and technology transfer from early development through commercial manufacturing.
- Translate user needs into functional requirements and design outputs.
- Support Human Factors Engineering (HFE) activities.
- Develop specificati...
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