Senior Product Development Engineer
7 hours ago
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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