Process Development Engineer

at  Confluent Medical Technologies

Salary Range:
$54,000.00 - $90,000.00
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.
Confluent Medical Technologies is growing! We’re looking for a Process Development Engineer to join our team in Warwick, RI team! You may be just who we are looking for!
As a uniquely qualified candidate, you will:

General Summary

• Support implementation of Lean Manufacturing and continuous improvement programs.
• Use root cause and statistical tools to evaluate issues and increase yields and efficiencies in the company.
• Use DOE and other tools to drive understanding and improved performance.
• Work with production teams to troubleshoot machine and process issues
• Support production product lifecycle changes.
• Perform IQ/OQ/PQ validations for new equipment and products following ISO13485.
• Interaction with key customer contacts and engineering staff.
• Work Closely with Quality Assurance to ensure all activates meet requirements, aid in root cause analysis, and corrective and preventive actions.

Principal Duties and Responsibilities:

• Drive assigned lean manufacturing and continuous improvement projects from initiation to successful completion. Manage improvement teams to maximize contribution of all employees.
• Develop, track and maintain metrics for key production accounts. Develop process control to reduce variation. Support production activities to ensure on time deliveries
• Preform IQ/OQ/PQ and other activities related to changes and implantation of new equipment and process improvements.
• Interact with customers, medical device engineers and quality/regulatory departments.
• Interact with outside vendors, suppliers, and consultants.

Education and/or Experience:

• BS in Textile Science & Engineering (preferred), Material Science, Mechanical Engineering, Chemical Engineering, Bio Medical Engineering or equivalent.
• Minimum of 5 years of experience in Engineering with a focus on Lean Manufacturing and continuous improvement.
• Familiarity with Solid works and CAD systems for design preferred.
• Certification in Lean and Statistical process required. Green belt six sigma preferred. Proven track record of implementing lean, visual factory and CI programs.
• Some direct experience with Knitting, Weaving, Braiding or Non-woven product development preferred.
• Must be capable of handling multiple projects/tasks at the same time.
• Knowledge of medical device regulations and/or qualifications within ISO13485 preferred.

Other Skills and Abilities:

• Good interpersonal relationship management and people skills. Strong team player.
• Excellent verbal and written communication skills.
• Proven problem solving skills.
• Strong computer skills; familiarity with Microsoft Office suite of products

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.

• Drive assigned lean manufacturing and continuous improvement projects from initiation to successful completion. Manage improvement teams to maximize contribution of all employees.
• Develop, track and maintain metrics for key production accounts. Develop process control to reduce variation. Support production activities to ensure on time deliveries
• Preform IQ/OQ/PQ and other activities related to changes and implantation of new equipment and process improvements.
• Interact with customers, medical device engineers and quality/regulatory departments.
• Interact with outside vendors, suppliers, and consultants