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).
- 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 specifications, design outputs, packaging, and verification plans.
- Perform risk management activities including DFMEA, PFMEA, and UFMEA.
- Contribute to requirements management, quality systems, and risk processes.
- Work cross-functionally in a fast-paced development environment.
Education & Experience
- Bachelor's or master's degree in engineering or related field.
- 510 years of experience in medical devices or combination products.
- Strong experience with drug delivery systems and combination products.
- Expertise in design controls, DHF, and product lifecycle management.
- Hands-on experience with risk management (ISO 14971).
- Knowledge of FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820.
- Experience with tools like JAMA and Windchill.
- Strong technical writing, communication, and organizational skills.
- Ability to work independently and manage multiple projects