Senior Medical Device Quality Engineer

Location: Santa Clara CA
Experience: (8 years preferred)

We are seeking an experienced Senior Medical Device Quality Engineer with expertise in Medical Device Quality Systems Design Transfer Risk Management and Regulatory Compliance. The ideal candidate will lead quality engineering activities for complex medical device products including surgical robotics platforms ensuring compliance with ISO 13485 FDA 21 CFR Part 820 ISO 14971 MDD/MDR and other regulatory standards. This role requires strong experience in quality management CAPA FMEA statistical analysis and manufacturing readiness.

• 6-8 years of experience in Medical Device Quality Engineering
• Strong expertise in:
  • ISO 13485:2016/2019
  • FDA 21 CFR Part 820 (Quality System Regulation)
  • Medical Device Directive (MDD)
  • Medical Device Regulation (MDR)
  • Regulatory Compliance
  • Quality Management Systems (QMS)

• Design Transfer (DHF to DMR)
• Manufacturing Readiness
• Product Commercialization
• Production Support
• Process Validation
• IQ/OQ/PQ Qualification
• Manufacturing Quality

• Non-Conformance (NC) Management
• Corrective and Preventive Actions (CAPA)
• Internal Audits
• External Audits
• Change Control
• Document Control
• Continuous Improvement

• ISO 14971
• Risk Management
• Design FMEA (DFMEA)
• Process FMEA (PFMEA)
• System FMEA
• Application FMEA
• Risk Assessment
• Root Cause Analysis

• Design of Experiments (DOE)
• Statistical Process Analysis
• Reliability Analysis
• Descriptive Statistics
• Non-Parametric Statistics
• Data-Driven Decision Making

• Medical Device Manufacturing
• Surgical Robotics
• Product Quality
• Failure Analysis
• Engineering Change Management

• Cross-functional Leadership
• Project Management
• Stakeholder Management
• Team Mentoring
• Problem Solving
• Communication Skills

• Lead design transfer activities from Design History File (DHF) to Device Master Record (DMR) while ensuring compliance with FDA and ISO 13485 requirements
• Support manufacturing readiness and production quality for complex medical device and surgical robotics products
• Own quality engineering activities for multiple subassemblies ensuring product quality manufacturability and regulatory compliance
• Investigate non-conformances using structured root cause analysis and drive effective CAPA implementation
• Develop maintain and update Design Process System and Application FMEAs in accordance with ISO 14971
• Lead qualification activities including Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ)
• Utilize statistical tools DOE and reliability analysis to support process improvements and data-driven quality decisions
• Maintain and improve Quality Management System (QMS) processes in compliance with FDA and international regulations
• Support internal audits external audits customer audits and regulatory inspections while ensuring timely closure of findings
• Collaborate with R&D Manufacturing Operations Regulatory Affairs Marketing and Quality teams to deliver compliant products
• Identify quality risks recommend mitigation strategies and drive continuous improvement initiatives

• Bachelors or Masters degree in Engineering Biomedical Engineering Mechanical Engineering or a related discipline
• Experience supporting surgical robotics or complex electromechanical medical devices
• ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) is preferred
• Lean Six Sigma Green Belt or Black Belt certification is a plus
• Experience with FDA inspections and global regulatory submissions

• Strong project planning and execution skills
• Ability to manage multiple quality initiatives simultaneously
• Excellent stakeholder communication and influencing skills
• Strong analytical and decision-making capabilities
• Proven leadership and mentoring experience
• Ability to work effectively in cross-functional and global teams