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Work Flexibility: Hybrid
Executes the innovation and development of assigned project elements with an emphasis on the manufacturing process, technology and procedures required for the manufacture of medical devices.
Independently determines and develops approaches to a variety of technical problems of moderate scope and complexity.
Monitor and report on project progress to ensure delivery on-time and on-budget.
Uses latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs.
Participate in PFMEA, Control Plan, SOP and PPAP generation associated with Manufacturing transfers and launches.
Specification to manufacture PCB and PCBA at supplier end.
Knowledge & understanding of Layout and Schematic development.
Handon experience to Perform DFM for PCB and PCBA on Valor and Altium.
Complete capability studies for in-process inspection and generate subsequent inspection documentation
Conduct MSA studies for sustaining products and processes
Review and approval of validation documentation
Selection of components and equipment based on analysis of specifications, reliability and regulatory requirements
Ensure adherence to the established processes and procedures as defined in the appropriate operation and material specifications
A bachelor’s degree in engineering. Biomedical, Electrical, Electronics Engineering preferred. Other technical bachelor’s degrees will be considered based on relevant experience
12+ years of experience; Medical device, automotive, manufacturing experience preferred
Hands on experience in manufacturing processes
Experience in one or more of these areas: plastic molding, ultrasonic/RF welding, sealing, thermo-forming or sewing processes strongly preferred
Must be able to read and interpret complex engineering drawings and have working knowledge of geometrical dimensioning and tolerancing (GD&T)
Lean Six Sigma green or black belt preferred
Demonstrated communication (written & verbal), presentation, partnership and influencing skills
Proven ability to effectively work in a fast paced, dynamic and results oriented team environment
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