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About the Role

Leads the management of the design and development of biomedical textile products, manufacturing methods, and test methods with a focus on design feasibility, customer communication, design control documentation, and project timelines, to ensure products meet and exceed customer expectations.

Responsibilities

• Consult and guide customers to biomedical textile solutions by leveraging textile forming techniques such as braiding, knitting, weaving, as well as post-processing methods to create novel structures.
• Collaborate with Sales & Sales Engineering to gather voice of customer, evaluate new project opportunities, and make strategic project decisions.
• Represent Cortland Biomedical as biomedical textile design expert.
• Establish design and manufacturing feasibility of new products.
• Document engineering work in protocols and reports.
• Establish documentation best practices and mentor junior engineers.
• Own execution of engineering changes and CAPAs.
• Create and maintain design control documentation including traceability matrix, design and development plan, and other quality management system (QMS) documentation in compliance with Cortland Biomedical QMS standards.
• Provide continuous improvement ideas and solutions for design and development documentation.
• Drive the progression of development projects through the Cortland Biomedical design and development phase gate process through execution and documentation of timely cross-functional design reviews in compliance with Cortland Biomedical QMS standards.
• Provide continuous improvement ideas and solutions for design and development processes and systems.
• Collaborate with engineering, operations, and quality to ensure all QMS documentation is completed in a timely manner, consistent with the project timeline.
• Manage the details of development projects including resources, timelines/Gantt charts, deliverables, milestones, recurring calls, and overall engineering communication with internal and external teams.
• Support the management of the development engineering project portfolio to ensure adequate resources are available to achieve simultaneous project milestones.
• Provide informal mentoring and/or supervision to junior team members.
• Identify raw material suppliers and work toward their approval on Cortland Biomedical’s approved supplier list (ASL).
• Represent Cortland Biomedical as expert in the properties and performance of biomedical textile fibers.
• Support the creation and validation of test methods for the analysis of design concepts.
• Ensure project compliance with all ISO 13485 requirements outlined in Cortland Biomedical’s Quality Management System.
• Provide continuous improvement ideas and solutions, in line with Quality initiatives.
• Develop new technological solutions to manufacturing challenges including identification of new equipment and use of digital tools, where applicable.
• Support transfer of new product development processes to commercial production.
• Participate in continuous improvement to improve processes, eliminate problems, streamline operations, or other areas as defined by management.
• Expand Cortland Biomedical’s expertise in state-of-the-art engineering, manufacturing methods, and test methods through technical journals, seminars, advance degree programs, etc.
• Comply with and participate in safety protocols and initiatives.
• Additional tasks as assigned.

Requirements

• Minimum of 5 years of experience, 10 years+ preferred, in an engineering function within a manufacturing environment - especially in highly regulated industries (medical device, energy, aerospace, automotive, etc.), medical textiles or medical device preferred.
• Employee may have to lift documents/work materials up to 30 pounds in weight.
• Employee may have to lift tools up to 50 pounds in weight.
• Employee will have to be able to walk/climb to a variety of primary work locations, including traveling by air/auto to remote sites.
• 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 can work in front of a personal computer and telephone for long periods of time.
• Will have repetitive motions that include the wrists, hands, and/or fingers.

Skills

• Knowledge of the physical and mechanical characteristics of polymers, fibers, yarns, and fabrics preferred
• Experience with documentation and traceability requirements for highly regulated industries preferred
• Effective verbal communication skills and comfortable interacting with team members, customers, and vendors at all levels
• Effective technical writing skills consistent with writing engineering reports and quality management system documentation
• Demonstrated creative problem solving and effective engineering decision-making skills
• Experience with Enterprise Resource Platforms (ERP) a plus
• Demonstrated ability to work well independently and as a team member
• Self-starter able to work under minimal supervision
• Capable of generating and delivering internal and external presentations at all levels

Location

• 850 Lime Hollow Rd. Cortland, NY 13045

Work Type

• In-office Monday – Friday
• Full-time

Experience Level

• Minimum of 5 years of experience
• 10 years+ preferred

Education Level

• BS Degree in Mechanical, Textile or Biomedical Engineering, or related degree from an accredited university

Salary/Compensations

• $96,500 - $144,750

Benefits

• Enerpac is an Equal Opportunity Employer.

About the Company

• 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.
• Enerpac Tool Group Corp. is a premier industrial tools, services, technology, and solutions provider serving a broad and diverse set of customers and end markets for mission-critical applications in more than 100 countries.
• The Company makes complex, often hazardous jobs possible safely and efficiently.
• Enerpac Tool Group’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 Milwaukee, Wisconsin.
• Enerpac Tool Group common stock trades on the NYSE under the symbol EPAC.

Equal Opportunity

• Enerpac 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: recruiter@enerpac.com