Job Description

Roles & Responsibilities :

uthor 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
bility to work independently and manage multiple projects in a fast-paced environment.

Sr. Product Development Engineer

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