Position Overview

Lead the projects associated with developing and optimizing processes to manufacture new medical devices, combination devices and/or line extensions. Provide hands-on support to characterize processes and implement innovative fixtures and automation to build optimum processes. Develop small scale process transitioning into large scale processes. Spearhead the root cause analysis investigations related to product and process inconsistencies. Work closely with internal Manufacturing, Quality, and Regulatory teams and outside vendors. Job duties:
  • Initiate process conceptualization and development on bench scale.
  • Spearhead scale up activity through pilot and manufacturing in conjunction with Manufacturing Engineering.
  • Implement fixtures, equipment, and automation to create optimum manufacturing processes and product testing.
  • Formulate hypothesis, design experiments (DOE), collect and analyze data and present solutions to R&D and manufacturing teams.
  • Support validation and verification of product, equipment, and processes.
  • Spearhead the root cause analysis investigations related to product and process failures.
  • Support builds for new products in prototype, pilot, and production setting, including training of Operators, Technicians, and Manufacturing Engineers.
  • Review and develop manufacturing documents (e.g., MP, BR, BOM, pFMEA etc.).
  • Spearhead cost reduction steps to improve existing processes.
  • Document process and product investigations.
  • Execute process development and issue resolution with minimum supervision.
  • Perform additional responsibilities as assigned.
    1. Bachelor’s Degree in Engineering or related field of study.
    2. A minimum of four (4) years of hands-on process, manufacturing engineering experience in the medical device industry.
    3. Experience in development of pilot processes.
    4. Strong technical and hands-on skills including validation experience in scale up.
    5. Proven ability to design, execute, and analyze processes using designs/experiments.
    6. Proficiency in SolidWorks and fixture/tooling design.
    7. Proficient computer skills including MS Word, Excel, PowerPoint, Outlook, Teams, and Statistical Software (Minitab/JMP).
    Desired Qualifications
    1. Experience working on products from bench scale to manufacturing and troubleshooting.
    2. Ability to read and prepare technical documentation, including manufacturing and R&D procedures, specs, and engineering drawings.
    3. Ability to prioritize and meet deadlines in a timely manner.
    4. Good problem-solving skills.
    5. Ability to work individually and with teams.
    6. Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development, characterization, and optimization.
    7. Proven knowledge of Lean/Six Sigma techniques (Green or Black Belt a plus).