TechDigital Group
Quality - Quality Risk Management Specialist
TechDigital Group, Bothell, Washington, United States, 98021
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.
Responsibilities:
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, conduct hands-on execution, statistically analyze results, and document 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. 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 #J-18808-Ljbffr
Responsibilities:
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, conduct hands-on execution, statistically analyze results, and document 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. 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 #J-18808-Ljbffr