What are the responsibilities and job description for the Sr. Product Development Engineer position at Katalyst CRO?
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.
- 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.