What are the responsibilities and job description for the Manufacturing Engineer (medical device) position at TekOne IT Services Pvt. Ltd.?
Job Title - Manufacturing Engineer
Location - North Haven, CT (Onsite)
Location - North Haven, CT (Onsite)
- 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.
