Sr. Product Development Engineer

Enerpac Tool Group Corp • Munsons Corners, NY

2d • Onsite

About The Position

Cortland Biomedical, a wholly owned subsidiary of Enerpac Tool Group, custom builds high-performance biomedical textile structures. The company leverages over 40 years of experience in textile engineering and advanced fabric design to create braided, knitted, and woven products for the biomedical sector. They offer comprehensive design, development, and manufacturing services, along with a variety of biomedical materials. This role reports into the Sales & New Business Development organization and is responsible for leading the design and development of biomedical textile products, manufacturing methods, and test methods. The focus is on design feasibility, customer communication, design control documentation, and project timelines to ensure customer expectations are met and exceeded.

Requirements

• BS Degree in Mechanical, Textile or Biomedical Engineering, or related degree from an accredited university
• Minimum of 5 years of experience in an engineering function within a manufacturing environment
• Experience in highly regulated industries (medical device, energy, aerospace, automotive, etc.)
• 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
• 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

Nice To Haves

• 10 years+ experience in an engineering function within a manufacturing environment
• Experience in medical textiles or medical device
• Knowledge of the physical and mechanical characteristics of polymers, fibers, yarns, and fabrics
• Experience with documentation and traceability requirements for highly regulated industries
• Experience with Enterprise Resource Platforms (ERP)
• Occasional ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like.
• Occasional ascending or descending ladders, stairs, scaffolding, ramps, poles, and the like.

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. Establish best practices and mentor junior engineers.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior