Sr. Product Development Engineer

Sr. Product Development Engineer Katalyst Healthcares & Life Sciences - 4.0 Providence, RI Job Details Contract 2 hours ago Qualifications Developing medical devices Requirements specification Technical documentation New product development ISO standards Bachelor of Science Engineering Bachelor's degree in engineering Bachelor's degree Packaging Design failure mode and effects analysis (DFMEA) Master of Science Requirements analysis Risk management Organizational skills Technical writing Design controls Packaging design Quality systems Manufacturing Senior level Communication skills Regulatory compliance management FDA regulations Product lifecycle management 10 years

Full 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.