ROLE;MANUFACTURING ENGINEER (HIGH PRIORITY)

LOCATION;North Haven, CT (Onsite)

Please send us profiles suiting the JD and experience (10-18 yrs overall, minimum 6-10 yrs in medical device domain ).

The following is the unfit criteria:

• Senior candidates with more than 18 yrs (eventhough matching JD).
• Candidates without manufacturing exposure
• Candidates with Medical devices experience only in CAD, SAMD, software development, coding etc.

Please look for these key words:

Orthopedic implants, manufacturing process, continuous improvement, six sigma process, Statistical process control, Minitab operations, process capability, NPI, Impact assessment, Change management, CAPA. DOE, PLM, process validations (IQ, OQ, PQ), Class-2 and 3 medical devices etc.

Experience levels 10 ~ 20 Years band

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.

Qualification:

BS Degree in Packaging Science, Mechanical Engineering or Equivalent/MS Engineering
Min 3 yrs. Applicable Experience in packaging engineering, medical devices, pharmaceutical or related industry preferred. Broad knowledge of Mechanical/Manufacturing Engineering.