Lead welding process development, including microscale hermetic welds, feedthrough integration, and cleanroom-compatible processes.
Develop and implement process characterization strategies using Design of Experiments (DOE) to optimize parameters and reduce variability.
Apply statistical analysis tools (e.g., Cp/Cpk, yield, reliability metrics) to evaluate process capability and performance.
Troubleshoot and resolve complex design, process, and materials issues in Class III implantable medical device manufacturing.
Support process transfer from development to pilot and full-scale production, ensuring validation and scalability.
Contribute to capital equipment specification and procurement to support manufacturing process needs.
Requirements
Bachelor’s degree in Engineering required; Master’s degree preferred.
Minimum 7–10 years of experience in process engineering, including medical device manufacturing (Class III experience highly desirable).
Hands-on expertise in welding and automated manufacturing processes (resistance/laser welding, silicone molding, motion control, fluid dispensing, vision inspection).
Strong background in statistical analysis, Six Sigma, failure analysis, process validation, and process characterization using Design of Experiments (DOE).
Advanced technical proficiency in process control, mechanical modeling, and engineering drawings (SolidWorks and/or ProEngineer).
Ability to analyze complex data, drive technical solutions, and collaborate cross-functionally with R&D, Quality, Regulatory, Manufacturing, and Supply Chain.
Strong communication skills; proficient in English and MS Office/PLM systems (MS Project and statistical software a plus).
Benefits
Medical, dental and vision coverage*
Health Savings, Health Reimbursement, Flexible Spending/Dependent Care Accounts
TeleHealth options
401k plan with company match*
Company paid life/ad&d insurance
Additional supplemental life/ad&d coverage available
Company paid Short/Long-Term Disability coverage (STD/LTD)