Manufacturing Engineer

About the role

This position is responsible for hands-on troubleshooting and repairing medical devices, developing and validating refurbishment and recertification processes, and improving manufacturing and production processes. The engineer will ensure serviced and recertified medical device products meet required safety, performance, quality, and regulatory standards.

Qualifications

• Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related discipline.
• 2+ years of relevant experience in medical device engineering, service, repair, recertification, manufacturing, or a related technical field involving regulated products.
• Strong hands-on electrical, electronic, mechanical, and electromechanical troubleshooting and diagnostic skills, with a solid understanding of electronics, power systems, and structured troubleshooting methodologies.
• Experience working with medical devices, medical equipment, electronics, or other regulated products.
• Ability to read and interpret electrical schematics, wiring diagrams, engineering drawings, service manuals, and technical specifications.
• Experience with diagnostic and test equipment, service software, and software/firmware updates.
• Knowledge and hands-on application of ESD principles and controls in production environments.
• Strong problem-solving, root-cause analysis, failure-analysis, and FMEA capabilities, with strong analytical and communication skills.
• Experience providing technical direction, training, mentoring, or supervision to technicians or technical personnel.
• Ability to develop clear technical documentation, work instructions, service procedures, service reports, test methods and other related documents.
• Experience with process, equipment, product, or fixture validation/verification, including working knowledge of IQ/OQ/PQ.
• Demonstrated experience with continuous improvement and familiarity with lean manufacturing principles.
• Ability to work independently, manage multiple priorities, and perform effectively in an onsite, hands-on environment.
• Familiarity with ISO 13485, FDA requirements, CAPA, and medical device quality systems.
• Prior servicing experience with medical devices and equipment preferred.

What you'll do

• Troubleshoot, diagnose, repair, test, calibrate, and maintain medical devices, including mechanical, electrical, electronic, electromechanical, software, firmware, and system-performance issues.
• Perform complex troubleshooting and failure analysis using schematics, service documentation, system data, diagnostic tools, calibrated test equipment, fixtures, torque tools, multimeters, and software-based procedures.
• Respond to scheduled and unscheduled service needs to support system reliability, uptime, and customer satisfaction.
• Analyze discrepant production components, assemblies, and field returns; identify root causes and implement corrective and preventive actions.
• Provide remote technical support, escalate complex and unfamiliar technical issues appropriately, and collaborate with R&D Engineering, Quality, Customer Service and other cross-functional teams.
• Supervise, train and mentor technicians on device operation, troubleshooting, maintenance, and safety procedures.
• Manage assigned spare parts, calibrated tools, service equipment, laptops, and other company assets in accordance with established controls.
• Develop, validate, and improve processes for inspecting, repairing, testing, and recertifying returned medical devices.
• Establish and maintain inspection, repair, testing, verification, and acceptance criteria to ensure recertified devices meet defined safety, performance, efficacy, and quality requirements.
• Develop manufacturing, assembly, and production testing processes through engineering changes
• Support post-manufacturing updates, including hardware changes, part replacements, and software or firmware updates for product launches and customer-specific requirements.
• Develop, update and maintain service procedures, work instructions, MPIs, test methods, fixtures, tooling, and process controls to improve serviceability, quality, and manufacturing efficiency.
• Analyze service, manufacturing, and failure data to identify recurring issues and drive improvements in reliability, quality, yield, turnaround time, efficiency, and cost.
• Provide service and failure-analysis feedback to R&D Engineering to improve product design, reliability, serviceability, and maintainability.
• Participate in failure investigations, nonconformances, CAPA, customer complaints, and root-cause analysis.
• Maintain complete and accurate service, testing, validation, and manufacturing records, including work orders, travelers, service reports, inspection documentation, parts usage, time records, and product-performance information using Oracle NetSuite, Arena, and internal systems.
• Performs other duties as required and assigned.

Additional information

This position is based at the Galvanize Therapeutics office in Redwood City, CA and requires you to be in the office. This is not a remote position.

Pay and benefits

This role pays betwee n $105,000 and $120,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.