Open Positions
Position Overview
Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product process; designing fixtures; and testing processes, equipment, and raw materials to ensure that the subassemblies and finished products meet requirements. Work closely with R&D counterparts, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch and continue leading product sustaining. Job duties:
- Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
- Review and develop manufacturing documents (MP, Routers, BOM, etc.).
- Draft and execute validation of product, equipment, and processes.
- Interface with other departments to solve production problems.
- Manage builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning.
- Analyze data and improve processes to assure robust/repeatable manufacturing processes.
- Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
- Manage process validation and product transfer activities across different manufacturing facilities.
- Investigate and test product processes, NCR’s, DC, and EO’s.
- Identify and execute on improvements, issues, or any process requirement with minimum supervision.
- Lead interdepartmental team on achieving goals.
- Perform additional responsibilities as assigned.
- Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or Material Science Engineering.
- Six (6) to eight (8) years of medical device industry experience.
- Statistical Knowledge (Green Belt or Black Belt).
- Strong written and verbal communication skills.
- Ability to effectively manage internal and external customer relationships as well as lead different key players on achieving a goal.
- Ability to design, execute, and analyze processes using designs/experiments. Ability to apply critical thinking and comprehensive technical translation in recommending process improvements.
- Ability to read and prepare technical documentation, including manufacturing and R&D procedures, specs, and engineering drawings.
- Expert proficiency with MS Word, Excel, PowerPoint, SolidWorks and/or other CAD systems.
- Experience with Guidewire and Balloon Catheters highly desirable.
- Ability to use and apply lean management principles to initiate, analyze, improve, and create engineering project and quality procurement systems.
- Experience working with manufacturing process development projects and transfer of R&D projects into high volume production.
- Ability to prioritize and meet deadlines in a timely manner.