Manufacturing Engineer

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

We7re looking for a hands-on Manufacturing Engineer to help bring innovative medical device products from development into reliable, scalable production.

~

Our client is seeking an experienced engineer who enjoys solving real-world challenges, working closely with product development teams, and turning designs into robust manufacturing processes. You7ll have the opportunity to make a meaningful impact across NPI, process development, pilot builds, manufacturing scale-up, and continuous improvement.

~

We invite candidates currently living in the San Francisco Bay Area with 5 or more years of medical device industry experience to apply. Candidates must possess US Work Authorization or US Citizenship. We are not able to accommodate H-1B Visa transfers at this time.

~

What Youll Do

• 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.
• Partner with Product Development Engineering to improve designs for manufacturability and assembly (DFM/DFA).
• Participate in prototype and pilot builds and help solve 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 structured root-cause analysis and data-driven problem solving.
• Drive improvements in quality, yield, cycle time, cost, and production efficiency.
• Support engineering changes and the transition of new designs into production.
• Collaborate with Quality, Regulatory, Operations, and external manufacturing partners to ensure processes 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.

~

What Were Looking For

• Bachelors degree in Mechanical Engineering or a related engineering discipline.
• 5+ years of manufacturing or process engineering experience, ideally within medical devices or another regulated industry.
• Experience supporting NPI, pilot builds, production scale-up, or manufacturing transfer.
• Strong understanding of manufacturing processes, assembly methods, tooling, fixtures, and process development.
• Experience with DFM/DFA and process improvement.
• Strong troubleshooting, root-cause analysis, and problem-solving skills.
• Experience with 3D CAD such as SolidWorks or equivalent.
• Working knowledge of process validation and regulated quality systems.
• Ability to work effectively with Engineering, Quality, Operations, suppliers, and contract manufacturers.
• Strong communication, documentation, and organizational skills.
• Ability to independently manage multiple projects and priorities.
• A hands-on mindset and willingness to get into the lab, shop floor, and production environment to solve problems.

~

Nice to Have

• Lean Manufacturing or Six Sigma experience.
• Experience with injection molding, CNC machining, sheet metal, additive manufacturing.
• Experience working with contract manufacturers and external suppliers.
• Familiarity with ERP/MRP systems.

~

Why Join?

Youe be joining a team where manufacturing engineering is more than keeping production running. Youd help shape how products are built, improve processes, solve challenging technical problems, and play an important role in bringing medical technology to patients. If you enjoy being close to the product, working through technical challenges, and seeing your engineering solutions become real products, this could be a great fit.