Senior Product Development Engineer
11 hours ago
Product Development Engineer
Cypress HCM is seeking a highly skilled Product Development Engineer to join our team. As a key member of our product development team, you will be responsible for leading the development process from concept to commercialization for our client companies.
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.
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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