Senior Product Development Engineer

4 weeks ago


Reston, Virginia, United States Cypress HCM Full time

Senior Product Development Engineer

Cypress HCM is seeking a highly skilled Senior Product Development Engineer to lead the development process from concept to commercialization. As a key team member, you will participate in the development process, leading the design and development of medical devices from concept through to market release.

Key Responsibilities:

  • Lead the design and development of medical devices from concept through to market release.
  • Create and refine product designs, including CAD models and technical documentation.
  • Conduct feasibility studies and risk analysis to ensure design functionality and safety.
  • Collaborate with cross-functional teams and external suppliers to meet project timelines.
  • Oversee validation activities, including Design Verification and product testing.
  • Ensure compliance with FDA QSR, ISO 13485, and other relevant regulations.
  • Communicate project progress and technical details to stakeholders.
  • Mentor junior engineers and participate in design reviews.

Requirements:

  • Experience with medical device design and development.
  • Experience in design for catheters and extrusions required.
  • Experience in design for reinforced shaft, delivery systems, and steerable catheters required.
  • Bachelor's degree in Mechanical or Biomedical Engineering (or equivalent experience).
  • Proficiency in SolidWorks 3D CAD.
  • Familiarity with FDA QSR and ISO 13485 medical device regulations.
  • Depth of knowledge in one or more technical areas (e.g., laser/resistance welding).
  • Knowledge of probability and statistics.
  • Demonstrated ability to bring products from concept to market.
  • Ability to interact with clients professionally and maintain customer focus.

$40-$60/hour



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