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Staff Quality Engineer
5 months ago
Client:
Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.
Job Location: (Hybrid) Open to San Jose or San Carlos locations
A Day In The Life Of Our Staff NPD Quality Engineer – ME/EE:
- Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
- Develop hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
- 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.
- Develop test plans, and test cases based upon the product and component level requirements.
- Use appropriate quality tools and statistical techniques to collect and summarize data, draw conclusions with confidence, determine sample sizes, apply data distributions, identify relationships between variables, calculate reliability, design and analyze experiments, determine process and performance capability, and make statistically supported decisions.
- Partner with Human Factors SMEs and R&D to assess the usability of a device throughout design and development
- Review and approve V&V system maintenance such as reworks and modification and tracking.
- Perform 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.
- Perform audits of Design History Files and support both internal and external audits.
- Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
- Support field service engineering requests and assess serviceability risks.
- Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
- Work collaboratively and efficiently in a fast paced environment with minimal supervision and guidance.
- Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
- As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
- Other QMS activities not specified here and as assigned.
About You:
- BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc.
- Minimum of 8 years of Engineering work experience in the medical device field with complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software.
- and a minimum of 3 years experience in a development QE function.
- Experience in meeting Design Control and DHF requirements with R&D teams.
- Well versed in the complete 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.
- Experience in electrical CAD tools, PCBA design workflow, PCBA build and bring-up. Have the ability to evaluate the design and characterize robotics and power control systems.
- Knowledge of electro-mechanical components including motors, gearboxes, motor controllers and compute into tight foam factor, considering sealing requirements for fluid ingress, EMC performance and thermal management.
- Hands-on experience and knowledge of key laboratory equipment: oscilloscope, DMM, spectrum analyzer, LCR/network analyzer, soldering equipment.
- Design and develop automated testing devices and fixtures to conduct functional and reliability tests on robotic subsystems.
- Use Design For Manufacturability, Assembly and Service-ability principles to reduce the cost, simplify assembly and serviceability.
- 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: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc
Workplace Type: Hybrid
