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Boston - New England

  • Advanced Manufacturing Engineer

    Westwood, MA

    Senior Advanced Manufacturing Engineer

    The medical device advanced manufacturing engineer responsibilities revolve around new product introduction and determining the most efficient processes for producing a high-quality product. You need to have good knowledge of plastic molding, extrusion, metal forming, joining methods and especially catheters and disposable devices. Other necessary manufacturing engineer skills include exposure to medical device contract manufacturing, project management, and a commitment to quality. If you’re also inventive and meticulous and would like to join a dynamic start up with FDA designated breakthrough technology, we’d like to meet you.

    Responsibilities

    • Design and develop manufacturing processes based on medical device design specifications; specifically catheters and other disposable medical devices.
    • Develop and test effective semi-automated and manual manufacturing systems.
    • Design and install equipment .
    • Organize and manage Contract Manufacturers (CMO’s).
    • Fixture design, development, and verification .
    • Train CMO’s in new and existing processes.
    • Collaborate with R&D engineers, contractors, suppliers, and CMO’s.
    • Utilize innovative technology to create new processes to maximize efficiency and output.
    • Create / Update Bill of Materials in Arena.
    • Create / Update Cost Estimates based on annual production volumes.
    • Supplier identification and coordination for equipment sourcing.
    • Develop complex experiments (including writing and executing protocols/reports) to qualify and validate manufacturing processes.
    • Develop training and documentation materials (e.g., work instructions, travelers, manufacturing procedures) for production to enable knowledge transfer of product/process to CMO’s.
    • Conducts research and development testing to determine effectiveness and compliance to quality standards for the manufacturing processes.
    • Recommends new tools and methodologies including cost estimates for design or production process enhancements.
    • Develops technical documentation to specify manufacturing processes, including documentation of equipment qualification, setup, and maintenance procedures.
    • Review engineering product specifications, CAD data/drawings, as part of the design review process to ensure they meet medical industry and manufacturing standards.
    • Approve part/drawing releases, and confirm / structure Bill of Materials (BOM).

    Requirements and skills

    • Bachelor’s Degree in manufacturing, Mechanical, or Biomedical Engineering with a minimum 8 years of experience in the medical device industry.
    • Startup environment teamwork skills.
    • Knowledge of manufacturing processes, fabrication methods, molding, extrusion, and manufacturing process equipment.
    • Understands injection molding, polymers, and commonly used materials in the medical device space, such as Nitinol, with working knowledge of metal processing.
    • Project management skills.
    • Problem-solving ability.
    • Knowledge of FDAQSR, ISO13485, ISO14971 Risk Assessment.
    • Proficiency in Microsoft Office Software, Solidworks, QMS, and ERP systems.
    • Demonstrated use of statistical tools, including Minitab, Sampling plans, and Statistical Analysis.
    • Demonstrated experience in Equipment / Process Validations IQ/OQ/PQ and FAT/SAT.
    • Experience with U/D/PFMEA.
    •  Excellent verbal and written communication skills.
    • Experience managing pilot production builds, planning, tracking, and execution.

     

     

     


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