Job
Description
PURPOSE OF THE POSITION: Design and develop mechanical design, prototype, manufacturing drawings and verification for innovative medical devices and solutions. Role & responsibilities 1. Support the design and development of new medical products to meet customer requirements within scope (e.g., performance and quality), schedule (e.g., on time delivery), and budget (e.g., price) constraints. 2. Support development of design solutions, at component and final assembly level, to complex technical problems where analysis of data requires an in-depth evaluation of many factors. Solutions require use of ingenuity and creativity. 3. Translate customers product requirements into achievable product specifications and design features. 4. Support FMEA (Failure Mode Effects Analysis) and risk analysis reviews on NPI (New Product Introduction) products. 5. Support a series of cross-functional design reviews throughout the NPI process. 6. Document product development progress conforming to operating procedures of the Product Lifecycle. 7. Coordinate proof-of-concept and design verification testing and write final test reports for communication with internal and external customers with minimal support. 8. Ensure new designs meet relevant Design History File (DHF) requirements. 9. Resolve quality problems associated with design and act as a technical resource to other cross- functional engineers as needed. 10. Implement design improvements on legacy products for cost savings. 11. Work effectively with cross-functional core team members. 12. Maintain current knowledge of best practices, new technologies, and equipment . 13. Work closely with suppliers, sourcing, manufacturing, and service teams to realize project goals. REQUIREMENT PROFILE: (Qualification, No. of yrs exp) a. Bachelors / Masters degree in Mechanical engineering. b. 4+ years of industry experience in concept to delivery of medical devices design and development. Knowledge of regulations relating to mechanical design in medical device industry. COMPETENCIES: (knowledge, skills and attitudes required to perform job): a. Fair knowledge of materials, manufacturing processes (e.g., plastic injection molding, machining, anodizing, soldering, automated assembly), sterilization, cable interconnect assemblies, bulk cable design principles, and advanced statistical techniques. b. Fair knowledge of PCBA design and processing c. Six Sigma Green or Black belt is a plus. d. Technical contribution through creative product design solutions that have been successfully launched into the market. e. Hands-on experience with mechanical CAD tools (Preferred Solid works, ePDM) for assembly design, parts design and BOM creation, GD&T and Prototype creation. f. Knowledge in Finite Element Analysis (FEA) theory and experience in performing mechanical and mold flow simulations. g. Working knowledge of additive manufacturing processes for rapid prototyping. h. Exposure to JMP and/or Minitab Statistical Analysis applications a plus Desired: i. Hands on experience in design and development of motion control, co-ordinate movement based medical devices.
