Sr. Product Development Engineer

Katalyst CRO; Providence (RI); On-site; USD 75,000 - 95,000; Full time

Job summary

Katalyst CRO is looking for a skilled professional in Providence, Rhode Island, to author and maintain design control documentation for drug-device and biologic products. The ideal candidate will have a B.S. or M.S. in Engineering, with at least 5 years of experience in a regulated medical device environment. Key responsibilities include ensuring compliance with FDA regulations and supporting product development. Strong knowledge of design controls and risk management practices is essential for this role.

Qualifications

• 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.

Responsibilities

• Author and maintain design control documentation for drug-device and biologic products.
• Ensure compliance with FDA, EU MDR, and internal quality standards.
• Support product development from early development through manufacturing.

Skills

Strong technical writing skills

Strong communication skills

Strong organizational skills

Risk management in accordance with ISO 14971

Experience with JAMA and Windchill software

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.