Manufacturing Engineer, Sr. Staff

Confluent Medical Technologies; Warwick (RI); On-site; USD 101,000 - 170,000; Full time

Job summary

A leading company in the medical technology space is seeking a Senior Manufacturing Engineer to drive Lean Manufacturing initiatives and improve production processes. The ideal candidate will have extensive engineering experience, strong problem-solving skills, and familiarity with medical device regulations. This role offers a competitive salary and the opportunity to work on innovative projects within a collaborative environment.

Qualifications

• 9-12 years of engineering experience focusing on Lean Manufacturing.
• Lean and Statistical process certifications required.
• Knowledge of medical device regulations and ISO13485 preferred.

Responsibilities

• Support implementation of Lean Manufacturing and continuous improvement programs.
• Lead lean manufacturing and continuous improvement projects.
• Perform IQ/OQ/PQ validations for new equipment and products.

Skills

Problem Solving

Communication

Teamwork

Education

BS in Textile Science & Engineering

BS in Material Science

BS in Mechanical Engineering

BS in Chemical Engineering

BS in Biomedical Engineering

Tools

SolidWorks

CAD systems

Microsoft Office

Job description

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Job Description:

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, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires. 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.

Salary Range:

$101,625.00 - $169,375.00

Job Responsibilities:

• Support implementation of Lean Manufacturing and continuous improvement programs. Use root cause and statistical tools to evaluate issues and increase yields and efficiencies.
• Use DOE and other tools to drive understanding and performance improvements.
• 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.
• Interact with key customer contacts and engineering staff.
• Collaborate with Quality Assurance to ensure activities meet requirements, and aid in root cause analysis, corrective and preventive actions.

Principal Duties and Responsibilities:

• Lead lean manufacturing and continuous improvement projects from initiation to completion. Manage teams to maximize contribution.
• Develop and maintain metrics for production accounts. Implement process control to reduce variation. Support on-time delivery.
• Perform IQ/OQ/PQ and activities related to equipment and process changes.
• Engage with customers, medical device engineers, and quality/regulatory departments.
• Coordinate with outside vendors, suppliers, and consultants.

Education and Experience:

• BS in Textile Science & Engineering (preferred), Material Science, Mechanical, Chemical, Biomedical Engineering, or similar.
• 9-12 years of engineering experience with a focus on Lean Manufacturing and continuous improvement.
• Familiarity with SolidWorks and CAD systems preferred.
• Lean and Statistical process certifications required; Green Belt Six Sigma preferred.
• Experience with knitting, weaving, braiding, or non-woven product development preferred.
• Ability to handle multiple projects/tasks simultaneously.
• Knowledge of medical device regulations and ISO13485 preferred.

Skills and Abilities:

• Strong interpersonal and team skills.
• Excellent communication skills.
• Proven problem-solving abilities.
• Proficiency with Microsoft Office suite.