Product Development Engineer
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Description:
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1. Lead product development activities to ensure customer requirements are defined, resolved into solutions and translated into product specifications for transfer to production.
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2. Engineering development of user-focused product solutions that are optimized for manufacture.
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3. Deliver Mechanical Design solutions for early stage and end-stage product development.
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4. Assess risk, manage risk as per ISO 14971.
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5. Prototype and test concept designs and initial engineering builds.
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6. Develop CAD models and perform tolerance stack-up analysis using SolidWorks.
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7. Conduct pilot production trials to assess concept feasibility and troubleshoot design risk.
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8. Develop product specifications and test methods, documenting in Product Input/Output format.
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9. Perform statistical analysis of product test data using Minitab or equivalent software.
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10. Verify designs through testing according to ISO 13485 and customer requirements.
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11. Work with the design team to define and complete product validation and usability testing.
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12. Collaborate with customers to complete design and technical reviews.
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13. Work with process development teams and production teams to complete transfers to production and pre-production planning.
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14. Work with project managers to define, plan, track, and report on product development projects.
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15. Lead the development of project proposals outlining cost, schedule, risk, etc.
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16. Liaise with customers to present and review proposals to secure project sales.
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17. Evaluate product non-conformances, assist in root cause analysis, and recommend design modifications if appropriate.
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Required Skills and Qualifications:
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18. Minimum 5 years' experience in product development for medical devices, ideally in highly regulated Class III devices.
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19. Demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance analysis, and design for manufacturing.
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20. Mechanical design experience is required.
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21. Highly experienced in product specification design; translation of design inputs to engineering outputs, tolerance stack-up analysis, as well as product testing.
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22. Experience working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
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23. Experience with medical device regulations including GMP, QSR, and ISO quality requirements.
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24. Experienced in risk management for medical devices and associated documentation processes.
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25. Excellent problem-solving, decision-making, and root cause analysis skills are required.
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26. Experience designing for manufacturability, particularly for plastics, and experience with related supplier management.
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27. Highly experienced in project management, from conception to delivery.
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28. Strong initiative and follow-through in executing project responsibilities, overcoming obstacles, and balancing multiple priorities effectively.
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29. Excellent communication skills, both written and verbal.
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30. Experience in team management and a demonstrated track record of being part of successful cross-functional product development teams.
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31. Proficiency in 3D CAD (e.g., SolidWorks) and MS Office Suite.
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Benefits:
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32. Healthcare benefits.
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33. Annual bonus.
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34. Pension.
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Others:
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35. To be considered for this role, forward your application to the link provided or contact me.
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