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Business Contribution:
Design and develop biomedical textile products and processes, manufacturing methods, techniques, practices and procedures with a focus on component processing to ensure the manufacture of products which meet and exceed customer expectations.
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Key Responsibilities:
- Develop textile and finishing processes for new products in medical device applications.
- Implement and optimize new product processes in a clean room environment
- Create PFMEAs, EIOQs, Procedures, Work Instructions, other QMS documentation in compliance with QMS standards in support of new product development
- Support the development and documentation of detailed manufacturing processes to support the company’s internal product development process and comply with QMS standards
- Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability
- Write and execute engineering, process characterizations and scientific protocols to support the creation of statistically based product specifications
- Responsible for transfer of new product development processes to commercial product production
- Support the creation, auditing and reviewing of test standards and methods for the analysis of design concepts and component assemblies
- Support the identification, tracking, logistics and installation of capital investments including potential travel for site acceptance testing
- Expand Cortland Biomedical’s expertise in state-of-the-art engineering, manufacturing methods and materials utilization through technical journals, seminars, advance degree programs, etc.
- <10% domestic and international travel in support of customers, engineering projects, site acceptance tests and training
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Direct Reports :
None
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Required Capabilities (describe scope of knowledge and ability of the position):
- BS Degree in Mechanical, Textile or Biomedical Engineering from an accredited university
- 3 - 5 years experience in an engineering function within a manufacturing environment - especially in highly regulated industries (medical, energy, aerospace, automotive, etc.).
- Familiar with the physical and mechanical characteristics of polymers, fibers, yarns and fabrics a plus
- Effective verbal communication skills and comfortable interacting with team members and customers at all levels
- Effective technical writing skills consistent with writing engineering reports and quality management system documentation.
- Must have 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 presentations to management, peers and labor force
- Demonstrated proficiency of design software such as AutoCAD or SolidWorks a plus
- Experience with Enterprise Resource Platforms (ERP) preferred
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HSQE Behaviors:
- To be a leader of safety and quality best practices including implementation of new processes and procedures to support
- 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
- Be able to lift documents/work materials up to 50 lbs in weight
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Leadership Expectations/Behaviors:
- Customer Focus
- Drive for Results
- Continuous Improvement
- Adaptability
- Engage and Inspire
- Effective Communication
- Build Relationships
- Decision Making
- Business Acumen
- Innovation
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