Senior Product Developer
6 days ago
The Product Development Lead will be responsible for leading product development activities, ensuring that customer requirements are met through effective translation into product specifications.
Key Responsibilities:
- Lead product development activity to ensure customer requirements are defined and resolved into solutions.
- Develop user-focused product solutions optimized for manufacture.
- Deliver Mechanical Design solutions for early stage and end-stage product development.
- Evaluate and mitigate risks according to ISO14971 standards.
- Test and refine concept designs and initial engineering builds.
- Create CAD models and perform tolerance stack up analysis using SolidWorks 3D CAD with expertise in complex assemblies and surface modeling.
- Conduct pilot production trials to assess concept feasibility and troubleshoot design risk.
- Develop Product Specifications and Test Methods, documenting them in Product Input/Output format.
- Analyze product test data statistically using Minitab or equivalent software.
- Verify designs through testing protocols and conduct testing as per ISO13485/customer requirements.
Requirements:
- A minimum of 5 years' experience in product development for medical devices, preferably in highly regulated Class III devices.
- Demonstrated understanding of manufacturing processes, mechanisms, materials, tolerance-analysis, and design-for-manufacturing is essential.
- Mechanical Design experience is required.
- Proven expertise in product specification design, translating design inputs to engineering outputs, tolerance stack up analysis, and product testing.
- Experience working under medical device design controls with knowledge of design verification/validation and design/process FMEAs is necessary.
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