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.

Benefits

Confluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients have allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

Pay

N/A

Schedule

N/A

Qualifications

Confluent Medical Technologies is an equal opportunity employer. Only qualified candidates will be contacted.