Mechanical Manufacturing Engineer

Mechanical Manufacturing Engineer

A well-established manufacturer is searching for a highly technical, hands-on Mechanical Manufacturing Engineer to support New Product Introduction (NPI), manufacturing process development, product launches, and ongoing production operations within a growing medical device manufacturing environment.

Manufacturing Engineer Responsibilities:

• Support New Product Introduction (NPI) from product development through production launch, including DFM/DFA reviews, prototype builds, process development, and production ramp-up.
• Develop, improve, and troubleshoot manufacturing processes for injection molding, plastics, medical tubing, and catheter products, with a focus on quality, efficiency, and consistency.
• Design and develop manufacturing equipment, tooling, fixtures, jigs, gauges, and production aids to support new and existing products.
• Provide hands-on engineering support on the manufacturing floor, troubleshooting equipment, tooling, molds, fixtures, and process issues and implementing sustainable solutions.
• Partner with Tooling and Process Engineering on mold development, trials, tooling qualification, and process optimization.
• Develop and optimize manufacturing cells, workstations, and processes to improve cycle time, throughput, yield, scrap, downtime, ergonomics, and overall manufacturing cost.
• Support the development and integration of automated and semi-automated manufacturing equipment, working closely with Automation Engineering and external suppliers.
• Conduct root cause analysis and implement corrective actions related to production, quality, equipment, and process issues.
• Support equipment and process validation, including IQ/OQ/PQ, engineering changes, and documentation in accordance with ISO 13485, FDA, GMP, and customer requirements.
• Collaborate cross-functionally with Product Development, Quality, Operations, Tooling, Maintenance, Automation, and Program Management to resolve technical challenges and improve manufacturing performance.
• Support the transfer of products, tooling, equipment, and processes from other facilities or external suppliers through installation, qualification, startup, and production ramp-up.
• Drive continuous improvement and Lean manufacturing initiatives focused on process capability, equipment reliability, automation, quality, and production efficiency.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Mechanical Engineering Technology, or related engineering discipline required.
• Plastics Engineering or related discipline preferred.
• 3+ years of experience in mechanical engineering, manufacturing engineering, or a related production engineering role.
• Experience working directly in a manufacturing environment.
• Experience with manufacturing equipment, tooling, fixtures, or process development.
• Experience supporting NPI through production launch preferred.
• Experience troubleshooting current production processes and equipment.
• Injection molding or plastics manufacturing experience strongly preferred.
• Medical device or other regulated manufacturing experience preferred.
• Experience working with automated or semi-automated manufacturing equipment preferred.

Take the next step in your Mechanical Manufacturing Engineer career and apply today!