Senior Service Engineer

About Galvanize Therapeutics Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.The Role The 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.Qualifications Education & 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 requirementsKnowledge 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 methodologiesAbility to read and interpret schematics, wiring diagrams, and technical manualsExperience with diagnostic tools, test equipment, service software, software updatesProvides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returnsExcellent problem-solving and analytical skills with attention to detailStrong communication skills to interface with technicians, research and development, planning, purchasing, regulatory, quality, customer support and other cross-functional groupsAbility to document servicing work clearly; write and develop work instructions.Leadership and mentoring capabilitiesProven 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 equipmentPrior 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 techniquesWhat 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 proceduresConduct 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.Provide training and support to repair technicians; train technicians in proper operation, maintenance, and safety proceduresLead and support escalations, ensuring timely resolution of critical service issues and customer complaintsMaintain accurate service records, reports, and documentation in compliance with company and regulatory standardsComplete work orders, travelers, servicing reports, inspection documentation and related documents using Oracle Netsuite, Arena and internal systemsSupport product upgrades, recalls, and field corrections as requiredSupport 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 requiredPerforms other duties as required and assigned.Location and Compensation 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. The role pays between $120,000 and $150,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.Benefits and Equal Opportunity 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.Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.#J-18808-Ljbffr