Senior Product Development Engineer
3 days ago
Cypress HCM is seeking a highly skilled and experienced Sr. Product Development Engineer to join our team. As a key member of our development team, you will play a critical role in the development process from concept and ideation through commercialization for our client companies.
Key Responsibilities:
Lead the design and development of medical devices from concept through to market release, ensuring compliance with FDA QSR and ISO 13485 regulations.
Create and refine product designs, including CAD models and technical documentation, utilizing expertise in SolidWorks 3D CAD.
Conduct feasibility studies and risk analysis to ensure design functionality and safety, collaborating with cross-functional teams and external suppliers to meet project timelines.
Oversee validation activities, including Design Verification and product testing, to ensure high-quality deliverables.
Requirements:
- Experience with medical device design and development, with a focus on design for catheters and extrusions.
- Proficiency in SolidWorks 3D CAD and familiarity with FDA QSR and ISO 13485 medical device regulations.
- Strong understanding of probability and statistics, with the ability to apply this knowledge to product development.
- Demonstrated ability to bring products from concept to market, with a strong customer focus.
- Ability to interact with clients professionally and maintain a customer-centric approach.
Compensation:
$40-$60/hour
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