The Engineering Manager is responsible for providing technical and strategic leadership to the manufacturing engineering team operating in an FDA/ISO regulated medical device manufacturing environment.
- Direct supervision of professional engineering staff including performance management and employee development.
- Ensuring production equipment is validated and maintained in good operating condition.
- Equipment reliability and process troubleshooting support to ensure productivity.
- Providing technical leadership and resource plans to support ongoing production. Must be focused on hitting plant unit delivery and financial commitments.
- Developing annual cost improvement initiatives with valid financial metrics.
- Capital project management and CER development.
- Transfer to manufacturing activities to support capacity expansion and new product launch initiatives.
- Ensuring compliance with EH&S requirements.
- Driving continuous improvement opportunities to support cost reduction and quality improvement requirements.
- Developing long term capital replacement and cost improvement strategies.
- Preparing annual budget requirements for engineering team including but not limited to staffing levels, training needs, and travel requirements.
- Developing, coordinating, prioritizing, and managing annual project plans to support business objectives.
- Coordinating plant projects with facilities management team.
- Experienced in developing visionary solutions to common problems
- Able to develop and lead teams to “breakthrough” performance
- Skilled at interacting with all levels of the organization
- A proven innovator willing to try new things
- Experienced in the product development life cycle for medical devices
- Highly skilled in medical device manufacturing and troubleshooting
- Other activities as required per business needs.
Scope of Position:
- Key contributor to attainment of Operating metrics, Project, and Quality objectives.
- Oversees as many as 20 or more technical staff, including engineers, and technicians.
BS in Engineering or technical degree required.
Skilled in LEAN 6σ techniques to drive performance improvements.
5+ years of medical device manufacturing experience in an FDA / ISO regulated environment with documented evidence of increasing responsibilities and examples of leading diverse teams with a proven history of success.