* 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
WHAT YOU WILL NEED:
* 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 t