Process Development Engineer, Staff

Salary Range:

$87,400.00 - $145,625.00

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes. We are looking for Process Development Engineer, Staff, to join our talented team in Warwick, RI.

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. Work hand-on at the shop floor while developing various processes and training-aids. 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 Lean manufacturing experience/knowledge Knowledge of various software such as Solidworks, AutoCad, Creo, Minitab 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 has 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. We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position. Confluent Medical Technologies is an equal opportunity employer. Only qualified candidates will be contacted. 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. Visit www.confluentmedical.com to learn more.