Sr. Design Quality Engineer- Service (Contract)

About The Team

Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

This position is responsible for ensuring product quality throughout the design lifecycle while serving as a key liaison between Engineering and the Service organization. This role drives design robustness, field performance improvement, and customer satisfaction by proactively incorporating serviceability, reliability, and field feedback into product development and continuous improvement initiatives. We are looking for someone that is highly motivated and solution oriented; you must be a self-starter, team builder, and excellent communicator. This is a 6-month contract opportunity.

A Day In The Life Of Our Contract Sr. Design Quality Engineer-Service at Noah Medical

• Act as the primary quality liaison to the Service organization.
• Support Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Serviceability (DFS) initiatives.
• Review hardware and system-related verification and validation strategies for the Service organization and ensure timely execution.
• Co-develop the project process validation strategy and review IQ/OQ/PQ/TMV protocols for service tools, equipment, software, and field processes.
• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management.
• Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.
• Review test plans, and test cases based upon the product and component level requirements, ensuring that appropriate statistical techniques are applied.
• Review and approve V&V system maintenance such as reworks and modification and tracking.
• Partner with cross-functional teams to collaborate on root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
• Support field service engineering requests and assess serviceability risks.
• Partner with PMO to apply project management tools to define project deliverables and establish a project schedule.
• Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness.

About You

• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc.
• Minimum of 4 years of Engineering work experience with a BS in the medical device or similarly regulated industry or minimum of 2 years of Engineering work experience with a PhD.
• Preferred 2 years experience in a development QE function in a regulated environment
• Experience in meeting Design Control and DHF requirements with R&D teams.
• Experience with Quality Management System to meet US FDA and ISO/MDR requirements.
• Experience with Risk Management, FMEA, Hazard Analysis, GD & T requirements.
• Experienced with statistical skills to define/train on test sample size and data analysis techniques.
• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems.
• Must be a self-starter, team builder, and excellent in verbal and written communication.
• Preferred: Experience working in a clinical setting, and or field service
• Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc

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