Product Development Engineer

4 weeks ago


Clearwater, United States Kelly Science, Engineering, Technology & Telecom Full time

Product Development Engineer | Direct Hire

Clearwater, FL | On-Site


Summary:

To conceptualize, prototype, design and bring new medical devices from inception through manufacturing and launch following a formal and regulated medical device design control process. Responsible for the life cycle of medical devices from initiation through post launch including sustaining design engineering activities.


Requirements:

  • Bachelors Degree-Mechanical, Manufacturing or Biomedical
  • 3 + Years of experience (Preferred Medical Device Experience) Open to other Regulated Industries
  • Design Experience-3D CAD Modeling



Responsibilities:


  • Development of new product concepts, prototypes, and final devices, developing design requirements, DFM, design/process FMEA, Risk Analysis, design verification/validation (methods, protocols, analysis, and reports), manufacturing transfer, process development, design reviews, and post-launch sustaining engineering.
  • Develop 3D models and 2D design specifications that integrate input requirements to meet user needs
  • Assist in developing project cost and timelines and managing project plan (e.g., Gantt)
  • Modify existing device designs to develop new product line extensions, improve design and manufacturability.
  • Manage project design phase deliverables and communicate project progress to management on a timely basis
  • Develop, organize, and maintain the design history file (DHF) for assigned projects



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