Product Development Engineer

JD:
The Candidates should be Bachelor in Mechanical Engineering and have min. 4+ years of experience in Medical domain Product design. Preferable experience concepts, designs, and specifications for machines, tools, fixtures, and products.

- Execute JOC (jobs, outcomes & constraints), VOC (voice of customer) methodologies and surgical procedure knowledge to define product and design options.
- Provide Innovative product, system and component design solutions.
- Perform high level research and development functions supporting existing products and processes.
- Own and deliver the development, process characterization and validation of the mechanical components and assembly process.
- Create or modify concepts, designs, and specifications for machines, tools, fixtures, and products.
- Create and manage component approval document (e.g. FAI, PFMEA, DFMEA, Cap Study, Supplier OQ)
- Design experiments to statistically analyze and validate parameters of new or modified components or processes.
- Write test protocols, conduct hands-on execution, statistically analyze results, and document completion reports for design verification testing.
- Lead or support design changes and ensure that current platform products have all regulatory filings and technical requirements completed.
- Release test protocols, completion reports, and other associated documents in Windchill.
- Establish appropriate testing strategy to ensure adequate safety factors or margins
- Perform product testing to ensure adequate safety factors or margins
- Formalize concepts, breadboards & prototyping.
- Coordinate integration of complex sub-system product designs
- Develop test protocols, conducts hands on execution, statistically analyzes results, and documents completion reports for design verification testing.
- Formulate tolerance stack-ups; Calculate stress & strain values; Develop free-body diagrams.
- Perform design of experiments (DOE) to statistically analyze and validate parameters of new or modified components or processes.
- Optimize the manufacturing process and the part/system assembly using the design for manufacturing and assembly (DFMA).
- Develop test methods for evaluating designs and conduct design reviews to meet device quality, capability, and functional requirements.
- Provide support to interpret the patents.
- Formulate tolerance stack-ups, calculate stress & strain values and develop free-body diagrams.
- Support CAPA, Complaints and NC investigations including planning, root cause analysis, risk analysis, action plans, and effectiveness checks.
- Assist in developing and monitoring project plan, budget, contingency plans and work estimation.
- Experience in GD&T (ASME Y14.5) and drawing interpretation to enable robust mfg. and CTQ parameters

Top Skills:
Creo, DFMEA, PFMEA, DFMA, FAI, Supplier OQ, DOE, CAPA , GD&T, Windchill

Additional Details:
Medical Device usability standards, FDA Standards, Project Management