Manufacturing Engineer I - Extrusion

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, 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.

We are looking for an Manufacturing Engineer I - Extrusion to join our Laguna Niguel, CA team. As a uniquely qualified candidate, you will:

• Participate in design and testing of tooling and fixtures for the manufacturing of tubing extrusion.
• Partner with the New Product Development team to effectively transfer products to production.
• Tirelessly strive to improve existing production processes and operations to increase/optimize yield, efficiency, or throughput.
• Purchase, set-up and validate production equipment (IQ/OQ/PQ) including writing protocols and reports.
• Optimize Manufacturing processes using engineering methods (e.g., Lean-Six Sigma) for design for manufacturing and for continuous process improvement.
• Develop experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
• Troubleshoot existing processes and develop new solutions to problems encountered.
• Excel at composing internal technical reports and other production-related documentation (e.g., WI/SOP/IP etc.), in accordance with the best engineering practice, company procedures, and regulatory requirement.
• Actively engage in coordinating the work of technicians, and others who assist in specific assignments.
• Contribute to the effectiveness of the quality system by actively participating in NCR’S, Complaints, CAPA’S and root cause investigations.
• Train production personnel as required on new manufacturing requirements per findings from complaints, CAPA’S and root cause investigations.
• Practice company safety and quality policies and procedures that actively require conformance.
• Work closely with customers to communicate product/project status and address questions and concerns.

Education and Experience:

• Bachelor’s degree in relevant discipline and have a degree in Mechanical or Chemical Engineering or equivalent.
• 1-2 years of related engineering/manufacturing hands-on experience in medical device, pharma or biotech industry experience is highly preferred.
• Have a good understanding of Lean Manufacturing principles.
• Strong problem-solving, organizational, analytical, and critical thinking skills
• Possess excellent communication skills - both written and oral.
• Experience with MS Office, Statistical process control software (MiniTab) and Solidworks is a plus.
• Lean Six-Sigma Greenbelt certified or equivalent preferred.
• Highly motivated and independent.

Qualified candidates will be contacted. No phone, fax or email inquiries from potential applicants, external recruiters or other interested parties, please.

We regret that we are unable to sponsor employment visas or consider individuals on a time-limited visa status for this position.