Position: Senior Quality Engineer III – $140k - $180k

Location: Sunnyvale, California

Join a pioneering company at the forefront of medical robotics, where you’ll have the opportunity to shape the future of minimally invasive surgery. Be part of an innovative, inclusive team that values integrity, continuous learning, and a passion for improving patient outcomes.

You will drive the reliability, quality, and safety of their innovative surgical systems. Collaborate with cross-functional teams to solve complex engineering problems and lead quality improvement initiatives in a fast-growing medical device company.

Key Responsibilities:

• Support product development, manufacturing, and sustaining activities for single-use and multi-use instruments and accessories.
• Lead New Product Introduction (NPI) efforts, ensuring smooth design transfer from development to manufacturing, and assist in production ramp-up.
• Manage production validation, MVP/MVR planning, execution, and documentation at our Sunnyvale site.
• Conduct failure analysis, review documentation, and implement defect containment strategies to resolve manufacturing issues.
• Represent Product Quality in cross-functional meetings, conducting data analysis and driving corrective actions for identified quality issues.
• Oversee root cause investigations and implement product/process improvements to reduce defects and enhance performance.
• Develop and refine quality standards, quality control procedures, test methods, and sampling plans for finished devices.
• Collaborate on design and process changes, conducting impact assessments and managing risk analysis (Top-down, Bottom-up).
• Work with suppliers on selection, qualification, and performance improvement to ensure product quality meets standards.
• Support internal and external audits and interact with auditors to ensure compliance with regulatory requirements.

Qualifications:

• Bachelor’s in engineering, Math, or Physics (Advanced degree preferred).
• 5+ years in Quality Engineering or manufacturing (4+ years in medical device environments).
• Deep understanding of CFR 21 820/ISO 13485 compliance, root cause analysis, and design control.
• Experience with process improvement, validation protocols, and quality tools.
• Knowledge of manufacturing metrics and proficiency in Excel data analysis (Pareto, charts, trend analysis).
• Familiarity with Tableau/Snowflake is a plus.