Manufacturing Engineer I

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 a Manufacturing Engineer I 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 extrusion and or balloons.Set-up and validate production equipment (IQ/OQ/PQ) including writing protocols and reports. Optimize Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvementDevelop experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reportsTroubleshoot processes and devise new solutions to problems encountered.Excel at composing internal technical reports and other production-related documentation, in accordance with the best engineering practice, company procedures, and regulatory requirementActively 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.Partner with the New Product Development team to effectively transfer products to production.Train production personnel as required on new quality manufacturing requirements and findings from complaints, CAPA’S and root cause investigations.Practice company safety and quality policies and procedures that actively require conformance.Tirelessly strive to improve existing production processes and operations to increase/optimize yield, efficiency, or throughput.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 Manufacturing Engineering or equivalent.0-3 years of related engineering/manufacturing 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 skillsPossess excellent communication skills - both written and oral.Familiar with MS Office, Statistical process control software (MiniTab) and SolidworksGreenbelt certified or equivalent preferred.Highly motivated and independent.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.