Senior Quality Engineer - Electromechanical Medical Devices

Location: Alameda, CA (Onsite)

We are seeking a Senior Quality Engineer to support the design, manufacturing, and lifecycle management of complex electromechanical medical devices. This role will partner closely with R&D, Manufacturing, and Operations to ensure product quality, regulatory compliance, and continuous improvement across PCB/PCBA assemblies and finished devices.

• Lead quality activities for electromechanical products, including PCB/PCBA assemblies
• Support design controls, risk management (ISO 14971), and product development efforts
• Drive investigations, root cause analysis, and CAPA for quality issues
• Ensure compliance with IEC 60601, FDA QSR (21 CFR 820), and ISO 13485
• Review and approve validation protocols, change controls, and technical documentation
• Collaborate with suppliers on quality performance and corrective actions
• Support audits, inspections, and continuous improvement initiatives

• Bachelor's degree in Engineering or related field
• 5-10+ years of quality engineering experience in medical devices
• Strong background in electromechanical systems and PCB/PCBA quality
• Working knowledge of IEC 60601, ISO 13485, FDA QSR, and risk management
• Experience with design controls, DHF, and product lifecycle processes
• Hands-on experience with root cause analysis and CAPA

• Experience supporting new product development (NPD)
• Familiarity with supplier quality and manufacturing environments
• Experience with global regulatory submissions or audits