Role: Manufacturing Engineer

Location: Mystic, CT (Onsite)

Job Description & Skill Requirement:

• Experience with Semi-automated and automated equipment

• Experience with process development in various different processing

• Experience working on print review and working with design on print updates

• Experience working in QMS and ERP systems

• Experience with IQ/OQ/PQ/TMV preferred

• Worked with cross functional teams

• 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 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.

• Participate on cross-functional project teams. Coordinate, manage, and document project work and progress, and recommend appropriate revisions.

• 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.