Process Development Engineer, Staff (Textiles)

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.
• Design, execute, and report out results from various engineering studies such as DOE, COV etc.
• Write and review various generic (or job specific) procedures, work instructions, and SOPs.
• 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 customers to understand product and validation requirements and offer strategy and solutions.
• Interact with outside vendors, suppliers, and consultants.

Education and /or Experience Required

• BS or MS in Mechanical Engineering, Textile Engineering, Biomedical Engineering, or equivalent.
• Minimum of 5-10 years of experience in manufacturing environment.
• 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.
• Proven problem-solving skills.

Preferred

• Industry experience in medical, textile, aerospace, or automobile.
• Knowledge of various textile products and processes, ideally covering braiding, knitting, weaving, and non-woven.
• Six Sigma green or black belt certified.
• Leverage Lean manufacturing experience/knowledge.
• Knowledge of various software such as Solidworks, AutoCad, Creo, Minitab.

Pay

Competitive salary commensurate with experience.

Schedule

Full-time, Monday-Friday, 8:00 AM - 4:30 PM.

Benefits

Health insurance, retirement plan, paid time off, and other benefits offered.

Qualifications

None specified.

Skills

Technical aptitude, problem-solving skills, communication skills, ability to work independently and as part of a team, proficiency in relevant software.

Benefits

Flexible work schedule, professional development opportunities, and a supportive work environment.