Our client, a well-known, fast growing, innovative Chicago area manufacturer of medical devices in the mechanical and electrical engineering markets seeks a Manager of Sustaining and Manufacturing Engineering position.
This position is accountable for providing overall leadership for the maintenance and continuous improvement of currently commercialized products and manufacturing processes. It will develop and drive effective methods to ensure cost, schedule, quality, and validation to performance metrics are achieved.
Key Deliverables
Organizational Leadership
- Provide leadership to the sustaining and manufacturing engineering team.
- Build a team that is focused on results with an advanced understanding of external and internal customers to effectively improve design and quality of products.
- Provide direction to direct reports.
Sustaining Engineering
- Collaborate with in-house teams and external customers to align project strategies for innovative product enhancements and improvements to meet business objectives.
- Provide effective cross-functional team leadership to deliver on-time results.
- Ensure the team contributes to inventions, new designs, or techniques to solve technical problems or improve existing products or processes.
- Foster learning and innovative practices.
Manufacturing Engineering
- Manage the team to apply lean principles to improve safety, quality and efficiency in manufacturing processes.
- Collaborate with in-house teams and external customers to align project strategies for innovative process improvements to meet business objectives.
- Provide effective cross-functional team leadership to deliver on-time results.
- Foster learning and innovative practices to maintain world class manufacturing processes.
Administration Standards
- Develop annual product and process improvement plan.
- Maintain process validation plans to ensure all processes are validated.
- Define actionable metrics to measure performance.
- Ensure compliance to all procedures and policies concerning quality, medical device regulations (ISO 13485, 21CFR820.30, 93/42/EEC, and CMDCAS]), safety, and human resources.
Health & Safety
- Establishes and/or maintains a safe work environment according to federal, state, and company policies and OSHA if applicable.
Qualifications, Skills and Working Conditions
Education and Experience
- BS degree in and engineering discipline or applicable field.
- 10 Years of previous experience in the medical device industry in an engineering or manufacturing capacity.
- 3 Years of experience in a leadership capacity with a proven track record in product or process improvements.
Specialized Skill and Knowledge
- Strong oral and written communication skills.
- Strong project leadership skills and experience with management of complex projects.
- Experience with the application of lean manufacturing principles. Black belt certification preferred.
- Successful track record of organizational development and delivering new products successfully to market
- Experience working independently and in a team environment.
- Working knowledge of Microsoft Office.
- Knowledge of regulatory requirements applicable to product development and manufacturing.