Sr. Product Development Engineer

Job Summary: 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. Roles & Responsibilities: Author and maintain design control documentation, including Design History Files (DHF).

Roles & Responsibilities : uthor and maintain design control documentation for combination drug-device and biologic products, including Design History Files (DHF). Ensure compliance with FDA, EU MDR, and internal quality standards throughout the product lifecycle. Support product development and technology transfer from early development through clinical and commercial manufacturing. Translate user needs into functional requirements and design outputs, including support of Human Factors Engineer

Job Title Systems Design Quality Engineer Job Description The Systems Design Quality Engineer supports the design control process, from validating design inputs to supporting verification, validation, and design transfer, ensuring compliance with regulatory and quality standards. Your role: Review and refine quality engineering documents, initiates quality improvement projects, and provides support in risk management.Resolve quality issues, utilizes post-market analytics for continuous improv

Do you want to change how the world creates? At Formlabs, we're building the tools that make it possible for anyone to bring their ideas to life, from cutting-edge products to life-saving medical devices. Our 3D printing technology powers innovation at more than 50,000 industry leaders worldwide, including Apple, Google, Tesla, New Balance, and NASA. Together, we're helping everyone design, prototype, and manufacture faster than ever before. We're a team of hands-on builders, engineers, and in