Senior Medical Device Quality Engineer

Job Title: Senior Medical Device Quality Engineer (Design Transfer & Risk Management)

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

Job Summary

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.

Required Skills

Medical Device Quality & Regulatory

• 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 & Manufacturing

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

Quality Systems

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

Risk Management

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

Statistical & Quality Engineering

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

Technical Skills

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

Leadership & Collaboration

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

Key Responsibilities

• 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

Preferred Qualifications

• Bachelor's or Master's 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

Soft Skills

• 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