Manufacturing Support Manager
Oversees the implementation of world class manufacturing processes and equipment using diversified knowledge and engineering principles that deliver product safety, quality as well as cost efficiency for the business’ biomedical textile products. Maintains processes, manufacturing methods, techniques, practices, and procedures in support of ISO13485:2016 International Standard for Medical Devices and Good Manufacturing Practices. Lead and participate in continuous improvement activity to ensure Cortland Biomedical meets/exceeds management and customer expectations. Creates and maintains professional development and strategic plans for a technical team of engineers, technicians and maintenance professionals. Promotes strong team collaboration between functional areas including operations, quality, new product development, and sales.
- Develop a high-performance manufacturing team by hiring, training, coaching, developing, and establishing performance and development objectives.
- Support Director of Operations and overall leadership team in setting operational strategy of the business.
- Establish, implement, and maintain safety policy and procedure in accordance with site requirements and at the direction from corporate health and safety.
- Ensure cross functional safety reviews for manufacturing equipment and processes.
- Lead establishment, implementation and maintenance of PFMEAs, Quality Plans, Procedures, Work Instructions, Forms and other QMS documentation once design is transferred to commercial production from new product development.
- Lead and mentor effective problem-solving activities including Corrective Action and Preventative Action (CAPA) assignments.
- Lead and facilitate engineering change including master list, timelines, job assignments, and customer communication when applicable.
- Support the creation and management of product BOMS and routers within the company’s ERP system and ensuring appropriate financial, engineering and Quality Management system (QMS) standards.
- Lead the budget, identification, tracking, logistics and installation of new capital equipment including potential travel to suppliers for site acceptance testing.
- Support execution of equipment installation and operational qualifications, process characterizations, performance qualifications and other scientific protocols to support the creation of statistically based product specifications.
- Lead creation, implementation and maintenance of Continuous Improvement methodologies including, but not limited to: 5S, Standardized Work, TPM, Pull Systems, etc. leveraging the corporate LEAD model.
- Manage key operational cost reduction initiatives for the site.
- Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability.
- Expand Cortland Biomedical’s expertise in state-of-the-art engineering, manufacturing methods and materials utilization through technical journals, seminars, advance degree programs, etc.
- <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training.
Engineers, maintenance personnel, technicians and/or technical specialists
Required Capabilities (describe scope of knowledge and ability of the position):
- BS Degree in engineering or operations management from an accredited university, masters preferred.
- Minimum of 5 years of professional relevant experience in the leadership of employees and manufacturing environment.
- 3+ years experience working within a ISO13485 or ISO9001 manufacturing environment (or similarly regulated).
- Effective verbal and written communication skills and comfortable interacting with team members and customers at all levels.
- Must have demonstrated creative problem solving and effective engineering decision making skills.
- Ability to make autonomous decisions based on thorough understanding of business objectives.
- Ability to work collaboratively with other functions.
- Proven ability to manage multiple priorities under tight timelines.
- Capable of generating and delivering presentations to management, peers and labor force.
- Familiar with the physical and mechanical characteristics of polymers, fibers, yarns and fabrics a plus.
- Knowledge of textile processing and equipment for braiding, knitting and/or weaving a plus.
- Experience with Enterprise Resource Platforms (ERP) preferred.
- To be a leader of safety and quality best practices including implementation of new processes and procedures to support.
- To always ensure that their acts or omissions do not present a danger to themselves, anyone else, the environment or the safe operation of any plant or equipment.
- To intervene and report any defect in equipment or practice or any dangerous circumstance or event which could affect HSQE performance.
- To comply with all HSQE customer and company requirements.
- Be able to lift documents/work materials up to 50 lbs in weight.
- Customer Focus
- Drive for Results
- Continuous Improvement
- Engage and Inspire
- Effective Communication
- Build Relationships
- Decision Making
- Business Acumen