Process Engineer
Business Contribution:
Design and develop biomedical textile products and processes, manufacturing methods, techniques, practices and procedures with a focus on flat fabric processing to ensure the manufacture of products which meet and exceed customer expectations.
Key Responsibilities:
Function as the Cortland Biomedical subject matter expert on knitting and weaving machines and processes.
Develop textile forming and finishing processes for new products in medical device applications.
Support the development and documentation of detailed manufacturing processes to support new product development.
Implement and optimize processes for manufacturing in a clean room environment.
Create PFMEAs, EIOQs, Procedures, Work Instructions, Process Flows, Routers, and other QMS documentation in compliance with Cortland Biomedical QMS standards.
Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability.
Write and execute engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically derived product specifications.
Responsible for the transfer of new product development processes to commercial production.
Support the creation, audit and review of test standards and methods for the analysis of design concepts and component assemblies.
Support the identification, tracking, logistics and installation of capital equipment including potential travel for site acceptance testing.
Support the design and manufacture of clean room compatible fixtures and tooling intended to aid manufacturing processes and interface with existing equipment.
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
Direct Reports:
None
Required Capabilities (describe scope of knowledge and ability of the position):
BS Degree in Textile or Mechanical Engineering from an accredited university
5+ years of experience in a textile engineering function within a manufacturing environment.
Expertise in knitting and weaving processes and experience with related machines.
Familiar with the physical and mechanical characteristics of fabrics, fibers, yarns, and polymers.
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
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
Leadership Expectations/Behaviours:
Customer Focus
Drive for Results
Continuous Improvement
Adaptability
Engage and Inspire
Effective Communication
Build Relationships
Decision Making
Business Acumen
Innovation
Business Contribution:
Design and develop biomedical textile products and processes, manufacturing methods, techniques, practices and procedures with a focus on flat fabric processing to ensure the manufacture of products which meet and exceed customer expectations.
Key Responsibilities:
Function as the Cortland Biomedical subject matter expert on knitting and weaving machines and processes.
Develop textile forming and finishing processes for new products in medical device applications.
Support the development and documentation of detailed manufacturing processes to support new product development.
Implement and optimize processes for manufacturing in a clean room environment.
Create PFMEAs, EIOQs, Procedures, Work Instructions, Process Flows, Routers, and other QMS documentation in compliance with Cortland Biomedical QMS standards.
Develop new technological solutions to manufacturing challenges including the use of digital tools for product documentation and traceability.
Write and execute engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically derived product specifications.
Responsible for the transfer of new product development processes to commercial production.
Support the creation, audit and review of test standards and methods for the analysis of design concepts and component assemblies.
Support the identification, tracking, logistics and installation of capital equipment including potential travel for site acceptance testing.
Support the design and manufacture of clean room compatible fixtures and tooling intended to aid manufacturing processes and interface with existing equipment.
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
Direct Reports:
None
Required Capabilities (describe scope of knowledge and ability of the position):
BS Degree in Textile or Mechanical Engineering from an accredited university
5+ years of experience in a textile engineering function within a manufacturing environment.
Expertise in knitting and weaving processes and experience with related machines.
Familiar with the physical and mechanical characteristics of fabrics, fibers, yarns, and polymers.
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
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
Leadership Expectations/Behaviours:
Customer Focus
Drive for Results
Continuous Improvement
Adaptability
Engage and Inspire
Effective Communication
Build Relationships
Decision Making
Business Acumen
Innovation