Patient Interface Senior Manufacturing Engineer

Are you a hands-on technical manufacturing engineer with electro mechanical design, production, assembly, and medical device experience? Come join our World Class Manufacturing team! Job Description

Develop and support PI production processes and equipment.  Resolve manufacturing and quality issues with PI manufacturing.  This includes project management, process and tooling design, troubleshooting, testing and validating.

 

Job Duties:

1. Develop, validate, and implement new production lines, equipment and processes.

2. Continually improve existing production processes with a focus on World Class Manufacturing principles and JIT, continuous-flow manufacturing.

3. Troubleshoot and resolve manufacturing, quality, and supplier issues.

4. Represent manufacturing in material dispositions, validations, design reviews, corrective and preventive actions and supplier audits.

5. Lead projects to improve product reliability/quality, reduce assembly cycle time, and reduce costs.

6. Develop, implement, maintain and revise procedures and documentation as required to ensure department activities adhere to current standards of quality and compliance.

7. Familiar with documentation requirements and procedures for an FDA regulated company.

8. Provides technical direction and assistance to production and junior technical personnel.

 

Experience Needed:

8 ? 10 years of experience in medical device manufacturing with medical disposable products a plus.

 

Education Requirements:

B.S. degree in engineering; Mechanical Engineering preferred.

 

Skills Desired:

1. Experience with manufacturing processes related to disposables production; plastic injection molding, metal forming/machining operations, dispensing/bonding processes, plastic materials welding, vacuum forming, heat sealing, bond strength testing, sterilization.

2. Experience with new product line development.

3. Familiar with manufacturing and assembly in a controlled clean-room environment.

4. Technical problem solving.

5. World Class Manufacturing principles and JIT, continuous flow production.

6. Computer: MS Office programs, ERP software, AutoCAD and SolidWorks.