Sr. Product Development Engineer
Katalyst Healthcares & Life SciencesProvidence, RI
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Overview
Remote
On-site
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.
- 5 10 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.
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FAQs About Sr. Product Development Engineer Jobs at Katalyst Healthcares & Life Sciences
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This job at Katalyst Healthcares & Life Sciences is located in Providence, RI, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
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