Overview

Summary - basic function of the role

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.

Work Schedule: Monday - Friday; evenings and weekends may be required

Location: In-office Monday - Friday

850 Lime Hollow Rd.

Cortland, NY13045

Salary Range: $86,330 - $129,500

This role is not eligible for sponsorship.

Job Duties and Responsibilities

• 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.
• Drive improvements to material requirements planning and controls.

Skills and Competencies

• 3-5 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) / Material Requirments Planning (MRP) preferred.

HSQE customer and company requirements:

• To be a leader of safety and quality best practices including support of new process and procedure development.
• 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.

Leadership Expectations:

• Customer Focus
• Drive for Results
• Continuous Improvement
• Adaptability
• Effective Communication
• Build Relationships
• Decision Making
• Business Acumen

Education and Experience

• 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.

Physical Demands

Employee may have to lift documents/work materials up to 50 pounds in weight. Employee will have to be able to walk/climb to a variety of primary work locations, this can include occasional ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like. Employee may move themselves in different positions to accomplish tasks in various environments including tight and confined spaces. Employee will need to move about to accomplish tasks or move from one worksite to another. Employee will need to operate machinery and/or power tools, motor vehicles, and heavy equipment. Employee will need to listen, understand, and speak with team members in person, telephonically, and electronically at all levels within a diverse workforce and with supported organizations. Employee will need to assess the accuracy, neatness, and thoroughness of the work assigned. Employee will remain in a stationary position, often standing or sitting for prolonged periods. Employee will use repeating motions that may include the wrists, hands and /or fingers. This will also include eye focus and fine finger dexterity required for threading high counts and small sizes of yarn into machines.

Work Environment

The primary work environment is in a controlled office space with temperature control. Long periods of sitting or computer work may be required. Secondary work environments may include areas that require additional PPE including, but not limited to eye, ear, foot and hand protection as well as specific gowning.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Direct Reports

Office staff, operations staff, engineers, maintenance personnel, technicians, and/or technical specialists.

Key External Contacts/Clients

General Manager

Production Manager

Engineering