Textile Product/Process Development Engineer
Textile Development Engineering Manager
Duties and Responsibilities:
- Develop medical textile-based structures to meet customer needs, with a focus on carrying products through development/validation and into production.
- Work as technical lead on development programs, under the direction of the textile development engineering manager and cross-functionally with project managers, development engineers, operations, and quality personnel.
- Lead teams through process development, characterization and optimization, validations (including IQ/OQ/PQ), and transfer to production.
Interact with customers to understand product and validation requirements and offer strategy and solutions.
Work with teams to understand product/process risk and characterize processes to mitigate risk.
- Support Quality deliverables such as PFMEAs by providing technical input.
Interact with outside vendors, suppliers, and consultants.
Education and /or Experience
BS or MS in Mechanical Engineering, Biomedical Engineering, Textile Engineering or equivalent.
- Minimum of 2-3 years developing textile products and processes, ideally covering braiding, knitting, weaving, and non-woven.
Hands on aptitude to dive in and provide technical leadership to teams.
Must be capable of handling multiple projects/tasks at the same time.
Have passion and enthusiasm for innovation.
o Proven problem solving skills
- Minimum of 1-2 years’ experience in a regulated industry. Medical device preferred.
- Knowledge of Design/Process Excellence (Six Sigma black belt certified is a plus) preferred.