Manufacturing Engineer - NPI & Scale-Up for MedTech

Curt Koland, Inc.; San Jose (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Curt Koland, Inc. is seeking a hands-on Manufacturing Engineer in the San Francisco Bay Area to help bring innovative medical device products from development into reliable, scalable production.

You will collaborate with product development teams and production teams to translate designs into robust manufacturing processes, while supporting NPI, pilot builds, process development, and continuous improvement initiatives.

Qualifications

• 5+ years of manufacturing or process engineering experience, ideally in medical devices or regulated industry.
• Strong troubleshooting, root-cause analysis, and problem-solving skills.
• Excellent communication, documentation and organizational skills.

Responsibilities

• Support new product introductions (NPI) from development through pilot builds and production release.
• Develop, improve and implement manufacturing processes, assembly methods, fixtures, tooling, and equipment.
• Collaborate with Product Development Engineering to improve designs for manufacturability and assembly (DFM/DFA).
• Participate in prototype and pilot builds and address manufacturing, yield, quality, and production challenges.
• Develop and improve work instructions, process documentation, workflows, and production methods.
• Support process characterization, DOE, process capability studies and validation activities.
• Troubleshoot manufacturing and product issues using root-cause analysis and data-driven problem solving.
• Drive improvements in quality, yield, cycle time, cost and production efficiency.
• Support engineering changes and transition of new designs into production.
• Collaborate with Quality, Regulatory, Operations, suppliers and contract manufacturers to meet medical-device quality requirements.
• Support contract manufacturers, suppliers, technology transfer and production ramp activities.
• Help develop and implement production fixtures, tooling, test methods, and equipment.
• Provide technical support and training to production teams as needed.

Skills

5+ years experience

Troubleshooting

Communication & documentation

Project management

Hands-on lab/shop work

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Job description

Curt Koland, Inc. is seeking a hands-on Manufacturing Engineer in the San Francisco Bay Area to help bring innovative medical device products from development into reliable, scalable production.

You will collaborate with product development teams and production teams to translate designs into robust manufacturing processes, while supporting NPI, pilot builds, process development, and continuous improvement initiatives.