Bachelor's or master's degree in engineering or related field.
5-10 years in medical devices or combination products.
Strong experience with drug delivery systems and combination products.
Expertise in design controls and product lifecycle management.
Hands-on experience with ISO 14971 risk management processes.
Knowledge of FDA regulations and ISO 13485 standards.
Experience with JAMA and Windchill tools.
Responsibilities
Author and maintain design control documentation, including Design History Files (DHF).
Ensure compliance with FDA, EU MDR, and ISO standards.
Support product development from early stages to commercial manufacturing.
Translate user needs into functional requirements and design outputs.
Support Human Factors Engineering (HFE) activities.
Develop specifications, packaging, and verification plans.
Perform risk management activities including DFMEA and PFMEA.
Benefits
Onsite role with opportunities in biotech hubs like Boston and Providence.
Full Job Description
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
