US Citizen
Green Card
EAD (OPT/CPT/GC/H4)
H1B Work Permit
Corp-Corp
W2-Permanent
W2-Contract
Contract to Hire
Consulting/Contract
UG :- - Not Required
PG :- - Not Required
No of position :- ( 1 )
Post :- 6th Oct 2023
• Perform equipment validation.
• Collaborate with Quality Engineering to provide manufacturing support.
• Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
• Need to conduct qualification, verification, and validation activities to produce medical devices.
• Work with CFT teams in troubleshooting problems on the production floor.
• Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.
• Drive the execution of various validation and PFMEA activities as per the project plan
• Execute Site acceptance test and Factory acceptance test based on North Haven
• Execute Validation Gap analysis of various product families based in Medtronic
• Plan and initiate CDPs associated with the various validation activities
• Co-ordination with stakeholders
• Collaborate with Quality Engineering to provide manufacturing support.
• Responsible for providing manufacturing engineering support to specific projects including change analysis, risk analysis, and manufacturing readiness.
• Should be experienced in conducting Time Study for various assembly line
• Should be experienced in Medical device manufacturing assembly lines
• Troubleshoot and resolve issues relating to the safety, efficacy, quality, cost, or delivery of components and finished devices.
• Need to conduct qualification, verification, and validation activities to produce medical devices.
• Need to be responsible for completing engineering work and contribute to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, six sigma, process studies, process improvements, and report preparation.
• Need to design, procure, and fabricate tooling and fixtures.
• Design, document, and improve manufacturing processes and operations that control the safety and efficacy of finished devices.
• Train, develop, and/or provide work direction to operators and technicians.
• Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.
• Participate in design control efforts related to risk analysis (failure mode and effect analysis) & design reviews.
• Work with CFT teams in troubleshooting problems on the production floor.
• Need to identify and implement process/product improvement alternatives to increase/optimize yield, efficiency, throughput, and/or performance.
• Design, develop, testing, and validate equipment and processes; analyze and interpret process models and recommend process improvements.