Sr. Product Development Engineer

Providence, RI, US • Posted 1 day ago • Updated 6 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Documentation
  • Regulatory Compliance
  • Product Development
  • Technology Transfer
  • Manufacturing
  • Functional Requirements
  • Human Factors And Ergonomics
  • FMEA
  • Requirements Management
  • Quality Management
  • Medical Devices
  • Design Controls
  • Risk Management
  • ISO 9000
  • ISO 13485
  • Technical Writing
  • Communication
  • Organizational Skills
  • Jama
  • Windchill
  • Management

Summary

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 739a91624f44cbd74845a5bf2b0c0a9d
  • Posted 1 day ago
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