About the roleThe Senior Service Engineer plays a leadership-level technical role focused on ensuring equipment, systems, or services are installed, maintained, troubleshooted, and repaired to the highest standards. This role serves as a technical and operational expert, providing servicing support including electromechanical and software disciplines to ensure equipment performance, regulatory compliance, and customer satisfaction.
QualificationsEducation & Experience:- Bachelor's degree in Engineering (Manufacturing, Mechanical, Biomedical, Electrical, or related)
- 5+ years of experience servicing complex medical devices or similar capital equipment in operations environment; knowledge of FDA QSR, ISO 13485, and GMP requirements
- Knowledge of ESD principles and hands-on application of ESD controls in production environments.
Skills:- Demonstrated electro-mechanical and/or process engineering capability; strong understanding of electronics, power systems, troubleshooting methodologies
- Ability to read and interpret schematics, wiring diagrams, and technical manuals
- Experience with diagnostic tools, test equipment, service software, software updates
- Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns
- Excellent problem-solving and analytical skills with attention to detail
- Strong communication skills to interface with technicians, research and development, planning, purchasing, regulatory, quality, customer support and other cross-functional groups
- Ability to document servicing work clearly; write and develop work instructions.
- Leadership and mentoring capabilities
- Proven ability to thrive in dynamic environments, balancing multiple priorities while maintaining quality and meeting delivery deadlines. Agile in adapting to changing demands and supporting time-sensitive requests in a service-oriented setting.
Preferred Qualifications- Prior servicing experience with medical devices and equipment
- Prior responsibility for process, equipment or product validation/verification; working knowledge of process validation activities (IQ/OQ/PQ) and fixture validation.
- Demonstrated ability in failure analysis and continuous improvement; knowledge of lean manufacturing techniques
What you'll do- Perform hands-on inspection, servicing, troubleshooting, diagnosis, repairs, testing of manufactured medical device systems using detailed work instructions, engineering documentation, service plan and reports. Maintain and adhere to documented process to ensure compliance with ISO 13485, FDA GMPs, Quality System Regulations, and Good Documentation Practices (GDP) requirements.
- Investigate and address product issues, inspect system and equipment performance, provide corrective repairs and improvements. Conduct functional, electrical, mechanical and diagnostic testing using calibrated equipment, test fixtures, torque tools, multimeters, and relevant software-based test procedures
- Conduct functional, electrical, mechanical, and diagnostic testing using calibrated equipment, test fixtures, torque tools, multimeters, and relevant software-based test procedures.
- Troubleshoot, diagnosis, and rework complex electrical and mechanical issues including alignment, faults codes and calibration deviations and escalate issues to engineering.
- Provides training and support to repair technicians; train technicians in proper operation, maintenance, and safety procedures
- Lead and support escalations, ensuring timely resolution of critical service issues and customer complaints
- Maintain accurate service records, reports, and documentation in compliance with company and regulatory standards
- Complete work orders, travelers, servicing reports, inspection documentation and related documents using Oracle Netsuite, Arena and internal systems
- Support product upgrades, recalls, and field corrections as required
- Support post-manufacturing updates such as hardware changes, part swaps, or software updates required for launch or customer specific needs.
- Leads and/or participates in process efficiency initiatives including yield and process improvement, material cost reduction, capacity enhancement.
- Actively participate in quality improvement initiatives by identifying issues, supporting engineering in investigations, corrective and preventive action implementation.
- Collaborate closely with Manufacturing leadership, NPI engineering, Quality, and Operations teams to resolve manufacturing challenges and support successful pilot builds and product introductions.
- Update and release servicing and procedures, MPIs, WRKs, FRMs, and engineering documents to correctly build, verify, and validate mechanical and electromechanical components across multiple products.
- Provide remote technical support to field personnel as required
- Performs other duties as required and assigned.
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.This role pays between $120,000 and $150,000 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.
