Process Development Engineer - Warwick, United States - Confluent Medical Technologies

Description

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Process Development Engineer

Salary Range:

Job Description:

Position: Textile Product/Process Development Engineer

Reports to: Engineering Manager

Position Summary:

• Develop medical textile-based structures to meet customer needs, with a focus on carrying
• products through development/validation and into production.
• Duties and Responsibilities:
• 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.
• Proven problem solving skills
• Six Sigma green or black belt certified is a plus
• 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.

About Us

Applying materials science to MedTech innovation.

Confluent specializes in expert design and development of large-scale manufacturing specializing in interventional catheter-based devices and implants. Our key capabilities include Nitinol components and tubing, balloon and complex catheters, high-precision polymer tubing, and implantable textiles. We operate in 8 state-of-the-art facilities across the United States and Costa Rica and currently employ over 2,000 employees. Confluent has earned the confidence of leaders in the medical device community through a proven track record of innovation, engineering, and manufacturing.