Responsible for developing production systems associated with predictable and efficient manufacturing of Contract Manufacturing Organization (“CMO”) for medical device products, this person focuses on leading and developing a team, implementing controlled production processes for a variety of manufacturing equipment, implementation of lean manufacturing techniques, and establishes a world class attitude in the delivery of products that exceed our customers’ expectations.
- Creation, implementation, and control of production processes for non-machining operations.
- Establish a culture of quality by utilizing metrics to continuously improve manufacturing performance.
- Design, procure, and standardize optimal tooling to achieve high quality levels and lower overall process time.
- Lead the implementation of lean manufacturing techniques.
- Develop, create, and perform process validation activities for current and new production processes.
- Coordinate the installation, relocation, and layout of new or existing production equipment & tooling.
- Document and create preventive maintenance plans for production equipment to optimize long-term capacity.
- Develop, improve, and optimize production processes.
- Assist in producing accurate cost estimates for contract manufacturing opportunities.
- Implement the use of SPC to ensure that machines and processes are operating predictably and to the full potential.
- Interpret GD&T design specifications to optimize machine fixturing and programming.
- Organize value stream mapping activities to identify waste and promote lean concepts.
- Provide engineering support in production departments to troubleshoot and resolve technical problems.
- Manage team work schedules, project timelines and budgets related to the design and integration of manufacturing equipment and systems.
- Research and understand state of the art manufacturing technology and propose implementation where appropriate.
- Design and create drawings for manufacturing-related materials.
- On-site manufacturing equipment management.
- Property strategy, design, and planning.
- On-site building management.
- Implementing a predictive, reactive, and preventive maintenance approach.
- Maintenance of heating, ventilation, and air conditioning (HVAC).
- Manage raw material inventory.
- Lead the receiving and data entry tasks to transfer materials into inventory.
- Lead logistics function in the preparation of out-going shipments, documentation, and stocking of packaging inventory.
- Lead operator employee selection, training and development.
- Establish general performance goals, offer feedback, evaluate performance.
- Define duties and create appropriate workloads and effective workflow.
- Provide direct supervision and mentoring to guide and develop staff to attain quality performance.
Education:
- Bachelor of Science Degree in Engineering, or other technical discipline.
Experience:
- 10+ years of medical device manufacturing experience.
- 4 years of leadership experience in lean/progressive manufacturing techniques (lean six sigma certification preferred).
- Thorough understanding of FDA production and product development regulations.
- Competency with ERP applications, MS Office applications.
- Strong written and verbal presentation skills.
- Product management experience (timeline or Gantt-chart development).
Excellent benefits package, including health, dental, vision, life and disability insurance, parental leave, 401K, vacation, and holidays.
Able Medical Devices is a leader in contract manufacturing and development. Able partners with companies seeking first class, outsourced services from design & development to comprehensive finished goods manufacturing. The company’s extensive expertise includes working with surgeons and OEM’s in spine, trauma and cardiothoracic markets. Able specializes in developing full surgical systems as well as custom instrumentation. Please visit our website www.ablemedicaldevices.com to learn more about the company.
Able Medical Devices is a portfolio organization of the J.M. Longyear family of companies. Headquartered in Marquette, Michigan, J.M. Longyear is a privately held asset-based manager with 150 years of experience growing long-term value. Longyear’s interests span a vast spectrum of markets that include forestry and land management, mining & metals, hardwood products, manufacturing, real estate, and medical device products.