Sr. Product Development Engineer

Katalyst CRO; Boston (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

Katalyst CRO is seeking an experienced professional in Boston, MA, to manage design control documentation for combination drug-device and biologic products. The ideal candidate has a B.S. or M.S. in Engineering and 510 years of experience within regulated medical device environments. Responsibilities include ensuring compliance with FDA and EU standards, supporting product development, and performing risk management. Familiarity with JAMA and Windchill is essential. Join Katalyst CRO for a dynamic work environment focused on innovation.

Qualifications

• 510 years of experience in a regulated medical device or combination product environment.
• Experience with combination products, preferably strong drug delivery systems experience.
• Experience with risk management in accordance with ISO 14971.
• Familiarity with FDA regulations, EU MDR, ISO 13485, and 21 CFR Part 820.

Responsibilities

• Author and maintain design control documentation for combination drug-device and biologic products.
• 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 manufacturing.
• Translate user needs into functional requirements and design outputs.
• Develop and support design outputs, specifications, and verification activities.
• Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.

Skills

Strong knowledge of design controls

Technical writing

Communication skills

Organizational skills

Ability to manage multiple projects

Education

B.S. or M.S. in Engineering or related discipline

Tools

JAMA

Windchill

Job description

Roles & Responsibilities

• Author 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 Engineering activities.
• Develop and support design outputs, specifications, packaging, and verification activities.
• Perform risk management activities, including authoring DFMEA, UFMEA, and PFMEA.
• Contribute to requirements management, quality systems, and risk management tools/processes to support development activities.

Requirements

• B.S. or M.S. in Engineering or related discipline.
• 510 years of experience in a regulated medical device or combination product environment.
• Experience with combination products, preferably strong drug delivery systems experience.
• Strong 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 JAMA and Windchill software
• Ability to work independently and manage multiple projects in a fast-paced environment.