Senior Development Engineer
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 https://www.cortlandbiomedical.com/
For further information on Enerpac Tool Group and its businesses, visit the Company's website at https://www.enerpactoolgroup.com/.
Summary – basic function of the role
Reports into the Sales & New Business Development (NBD) organization. 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.
Shift: Monday – Friday; 8 – 4:30 pm or 8:30 – 5:00 pm; flexible
Job Duties and 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, deliverables, milestones, recurring calls, and overall engineering communication with internal and external teams. Collaborate with project management to create and utilize project Gantt charts.
- 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.
- <20% domestic and international travel in support of engineering projects, customers, vendors, conferences, training, etc.
Skills and Competencies
- 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
Education and Experience
- BS Degree in Mechanical, Textile or Biomedical Engineering, or related degree from an accredited university
- 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 will occasionally be exposed to the following:
- Moving about to accomplish tasks or moving from one worksite to another
- Light work that includes moving objects up to 20lbs in all directions
Employee will constantly be exposed to the following:
- Remaining in a stationary position, often standing or sitting for prolonged periods
- Communicating with others to exchange information
- Repeating motions that may include the wrists, hands or fingers
- Assessing the accuracy, neatness, and thoroughness of the work assigned
- Operating machinery (laptop) or power tools
Employee will work onsite from New York location with Hybrid flexiblity. Given the need to drive to and from the facility or to client locations, employee will be exposed to different environmental conditions. While at manufacturing facility, employee would work from a temperature-controlled office setting. If required to go onto the manufacturing floor, designated PPE will be required.
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.
Key External Contacts/Clients
We are committed to recruiting, hiring, training, and promoting qualified people of all backgrounds, and make all employment decisions without regard to any protected status. We will ensure your application is fairly considered and if hired, you will have an equitable opportunity to give your best at work, not because we’re required to, but because it’s the right thing to do. Cortland will provide reasonable accommodations within the application process upon your request as required to comply with applicable laws. If you have a disability and require assistance in this application process, reach out to our Talent Acquisition Team for additional information.
If you’re looking for a unique, exciting career with variety and potential for growth, Cortland offers challenges & extraordinary rewards for people on a global scale
The above statements reflect the general details necessary to describe the principle functions of the job described and shall not be construed as a detailed description of all the work requirements that may be inherent in the job.