Utilize hands-on experience with medical device manufacturing processes, methods and tools to maintain and improve our hardware manufacturing assembly area. Frequently act as a key resource during product development and process improvement initiatives. Utilize design for manufacturing (DFMA) methods and tools to create and optimize manufacturing processes and influence design outcomes that are robust and efficient.
Work closely with the production, supply chain, and quality teams to assure manufacturing output is achieved. Exercise Lean and TOC principals to optimize our throughput and improve our quality levels.
Provide project management support for a large suite of enhancement and obsolescence projects as well as manufacturing process improvement initiatives that enable improved cost, quality and the continued supply of product for worldwide operations. This position is responsible for the selection of approach, methods, means and documentation for controlling, approving and validating manufacturing output. Must manage multiple projects of varied scope.
Qualifications (Knowledge, Skills & Abilities):
- BS Mechanical Engineering / Manufacturing Engineering / Systems Engineering / Electrical Engineering / Biomedical Engineering.
- 10+ years’ experience in the Medical Device industry.
- Working knowledge of project management software and tools (e.g. MS Project) and methods.
- Ability to coordinate multiple projects simultaneously.
- Strong interpersonal and communication skills.
- Strong problem-solving skills.
- Knowledge of QSR, ISO/EN and Quality System Standards.
- Technical writing skills.
- MS Office suite.