Manufacturing Engineer II

Cortland Biomedical custom builds high-performance biomedical textile structures, applying over 40 years of experience in textile engineering and advanced fabric design to braid, knit, and weave products for diverse biomedical applications. The company offers design, development, and manufacturing services along with a wide variety of biomedical materials. Cortland Biomedical is wholly owned by Enerpac Tool Group, a premier industrial tools and services company serving customers in over 25 countries.

About the role

Oversees the implementation of world-class manufacturing processes and equipment using diversified engineering principles to deliver product safety, quality, and cost efficiency for biomedical textile products. Maintains processes, methods, and procedures in support of ISO13485:2016 and Good Manufacturing Practices. Leads continuous improvement activities to meet or exceed management and customer expectations. Creates strategic plans for a technical team of engineers, technicians, and maintenance professionals while promoting collaboration across operations, quality, new product development, and sales.

Responsibilities

• Develop a high-performance manufacturing team by hiring, training, coaching, and establishing performance and development objectives.
• Support the Director of Operations and leadership team in setting operational strategy.
• Establish, implement, and maintain safety policies and procedures in accordance with site and corporate health and safety requirements.
• Ensure cross-functional safety reviews for manufacturing equipment and processes.
• Lead the establishment, implementation, and maintenance of PFMEAs, Quality Plans, Procedures, Work Instructions, Forms, and other QMS documentation post-design transfer to commercial production.
• Lead and mentor effective problem-solving activities, including Corrective Action and Preventative Action (CAPA) assignments.
• Facilitate engineering change management, including master lists, timelines, job assignments, and customer communication.
• Support the creation and management of product BOMs and routers within the ERP system, ensuring alignment with financial, engineering, and QMS standards.
• Lead the budgeting, identification, tracking, logistics, and installation of new capital equipment, including potential travel for site acceptance testing.
• Support execution of equipment installation, operational qualifications, process characterizations, performance qualifications, and other scientific protocols for statistically based product specifications.
• Lead the creation, implementation, and maintenance of Continuous Improvement methodologies (e.g., 5S, Standardized Work, TPM, Pull Systems) using the corporate LEAD model.
• Manage key operational cost-reduction initiatives.
• Develop new technological solutions to manufacturing challenges, including digital tools for product documentation and traceability.
• Expand expertise in state-of-the-art engineering, manufacturing methods, and materials through technical journals, seminars, and advanced degree programs.
• Drive improvements to material requirements planning and controls.
• Occasional domestic and international travel (less than 10%) in support of customers, engineering projects, site acceptance tests, and training.

Requirements

• BS Degree in engineering or operations management from an accredited university; master’s preferred.
• Minimum of 5 years of professional experience in leadership within a manufacturing environment.
• 3-5 years of experience in an ISO13485 or ISO9001 manufacturing environment (or similarly regulated).
• Effective verbal and written communication skills, with comfort interacting at all organizational levels and with customers.
• Demonstrated creative problem-solving and engineering decision-making skills.
• Ability to make autonomous decisions based on business objectives.
• Proven ability to manage multiple priorities under tight timelines.
• Capable of delivering presentations to management, peers, and the labor force.
• Familiarity with the physical and mechanical characteristics of polymers, fibers, yarns, and fabrics is a plus.
• Knowledge of textile processing and equipment for braiding, knitting, and/or weaving is a plus.
• Experience with Enterprise Resource Platforms (ERP) / Material Requirements Planning (MRP) preferred.

HSQE, Customer, and Company Requirements

• Lead safety and quality best practices, including support for new process and procedure development.
• Ensure personal actions or omissions do not endanger others, the environment, or the safe operation of plant or equipment.
• Intervene and report any defects in equipment, practices, or dangerous circumstances affecting HSQE performance.
• 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

Physical Demands

• Lift documents or work materials up to 50 pounds.
• Walk or climb to various work locations, including ladders, stairs, scaffolding, ramps, or poles.
• Work in different positions, including tight or confined spaces.
• Move between worksites or operate machinery, power tools, motor vehicles, or heavy equipment.
• Listen, understand, and communicate with team members in person, telephonically, or electronically.
• Assess the accuracy, neatness, and thoroughness of assigned work.
• Remain stationary (standing or sitting) for prolonged periods.
• Perform repeating motions involving wrists, hands, or fingers, including fine finger dexterity for threading yarn into machines.

Work Environment

• Primary work environment is a temperature-controlled office space; may require long periods of sitting or computer work.
• Secondary work environments may require additional PPE, including eye, ear, foot, and hand protection, as well as specific gowning.

Pay

$86,330 - $129,500

Schedule

Monday – Friday; evenings and weekends may be required. In-office at 850 Lime Hollow Rd, Cortland, NY 13045.

Direct Reports

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