Sr. Product Development Engineer

Position: Sr. Product Development Engineer (Onsite Contract)

We are partnering with a rapidly growing biotechnology organization in the Greater Boston area seeking an experienced Sr. Product Development Engineer to support the design and development of advanced drug delivery systems and combination products.

• Please submit candidates at the most competitive rates possible.
• Only candidates currently on your W2 will be considered.
• The client maintains strict compliance with these requirements.

• Location: Boston MA or Providence RI
• Work Arrangement: 100% Onsite (5 days/week)

The Sr. Product Development Engineer will play a critical role in the development of drug-device and biologic-device combination products. This includes supporting product development from early-stage design through clinical and commercial manufacturing while ensuring compliance with regulatory and quality standards.

• Author and maintain design control documentation 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-stage through commercialization
• Translate user needs into functional requirements and design outputs
• Support Human Factors Engineering activities
• Develop and manage design outputs specifications packaging and verification activities
• Perform risk management activities including DFMEA UFMEA and PFMEA
• Contribute to requirements management quality systems and risk management processes
• Collaborate cross-functionally to drive product development in a fast-paced environment

• Bachelors or Masters degree in Engineering or a related discipline
• 5 10 years of experience in a regulated medical device or combination product environment
• Strong experience with combination products preferably drug delivery systems
• In-depth knowledge of design controls DHF management and product lifecycle processes
• Experience with risk management in accordance with ISO 14971
• Familiarity with FDA regulations EU MDR ISO 13485 and 21 CFR Part 820
• Strong technical writing communication and organizational skills
• Experience with tools such as JAMA and Windchill
• Ability to work independently and manage multiple priorities