Manufacturing Engineer II

OverviewCORTLAND BIOMEDICAL – Who we are?Cortland Biomedical custom builds high-performance biomedical textile structures. The company applies over 40 years of experience in textile engineering and advanced fabric design methods to braid, knit and woven products that meet the demands of a diverse set of customers in the biomedical product space. The company also offers a full range of design, development and manufacturing services as well as a wide variety of biomedical materials. Never comfortable with the status quo, complex biomedical textile challenges are tackled with agility, credibility and curiosity.Cortland Biomedical is wholly owned by Enerpac Tool Group. Enerpac Tool Group is a premier industrial tools and services company serving a broad and diverse set of customers in more than 25 countries. The Company’s businesses are global leaders in high pressure hydraulic tools, controlled force products and solutions for precise positioning of heavy loads that help customers safely and reliably tackle some of the most challenging jobs around the world. The Company was founded in 1910 and is headquartered in Menomonee Falls, Wisconsin. Enerpac Tool Group trades on the NYSE under the symbol “EPAC”.For further information on Cortland Biomedical, visit the Company's website at For further information on Enerpac Tool Group and its businesses, visit the Company's website at .Summary – basic function of the roleOversees 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 requiredLocation: In-office Monday – Friday 850 Lime Hollow Rd. Cortland, NY13045Salary Range: $86,330 - $129,500This role is not eligible for sponsorship. Job Duties and ResponsibilitiesDevelop 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.<10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training.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 FocusDrive for ResultsContinuous ImprovementAdaptabilityEffective CommunicationBuild RelationshipsDecision MakingBusiness AcumenEducation and ExperienceBS 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 DemandsEmployee 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 EnvironmentThe 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 ReportsOffice staff, operations staff, engineers, maintenance personnel, technicians, and/or technical specialists.Key External Contacts/ClientsGeneral ManagerProduction ManagerEngineeringEEO StatementEnerpac is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected status in accordance with applicable federal, state, and local laws. We are committed to creating an inclusive environment for all employees and applicants and encourage candidates of all backgrounds to apply.If you are an individual with a disability and you need assistance or a reasonable accommodation during the application process, please reach out to us at: View email address on click.appcast.io you’re looking for a unique, exciting career with variety and potential for growth, Enerpac Tool Group offers challenges and rewards for people on a global scale.