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).
• 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.
• 5-10 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