Sr Manufacturing Engineer

Support development and manufacture of Medical Products performing validation, continue improvement and lean manufacturing activities including writing or verifying specifications, maintaining key process indicators, designing fixtures, developing test for processes, equipment and raw materials to ensure that the concepts, process, products and/or prototypes meet their requirements. Job duties:

• Support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures.
• Driver/Support on validation of product, equipment and processes, fixture design.
• Interface with other departments to solve production problems.
• Support the equipment maintenance program.
• Driver on investigation and testing of product processes as well Lean and Continues Improvement.
• Lead prototype and pilot production, facilities and planning activities, when appropriate.
• Lead manufacturing efforts associated with new product transfer between R&D and manufacturing, when appropriate.
• Additional duties and responsibilities as assigned.
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

Qualifications

1. Bachelor’s degree in engineering or science related field of study.
2. A minimum of four (5) years of related experience in medical device industry
3. Advanced English proficiency level
4. Solid proficiency with MS Office including Word, Excel, PowerPoint, Outlook, and Teams, SolidWorks and/or AutoCad and CMMS.
5. Strong knowledge of Statistics, DOE (Green Belt or Black Belt a plus).

Desired Qualifications

1. Read and prepare technical documentation.
2. Knowledge of standard machine shop equipment and processes.
3. Knowledge of medical and technical development.
4. Repair electrical malfunctions on process tools and equipment.

Physical

• Extended periods in the clean room.
• Extended periods of computer use.
• Extended periods of standing, walking and sitting.
• Ability to lift, push or pull, up to 25 lbs.
• May be required within the position to be in an environment that can include radiation exposure (such as in Cath labs).