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1.Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
2.Review hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.
3.Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management.
4.Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.
5.Review test plans, and test cases based upon the product and component level requirements ensuring that appropriate statistical techniques are applied.
6.Review and approve V&V system maintenance such as reworks and modification and tracking.
7.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.
8.Support field service engineering requests and assess serviceability risks.
9.Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
10.Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness.
11.Participate in clinical labs, formative and summative human factors studies to ensure product safety, usability, and regulatory compliance.
About You
1.BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc.
2.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.
3.Preferred 2 years experience in a development QE function in a regulated environment
4.Experience in meeting Design Control and DHF requirements with R&D teams.
5.Experience with Quality Management System to meet US FDA and ISO/MDR requirements.
6.Experience with Risk Management, FMEA, Hazard Analysis, GD & T requirements.
7.Experienced with statistical skills to define/train on test sample size and data analysis techniques.
8.Use Design For Manufacturability, Assembly and Service-ability principles to reduce the cost, simplify assembly and serviceability.
9.Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems.
10.Must be a self-starter, team builder, and excellent in verbal and written communication.
11.Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc.