该职位来源于猎聘
- Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
- Review 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.
- 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 in order 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.
- Participate in clinical labs, formative and summative human factors studies to ensure product safety, usability, and regulatory compliance. 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.
- 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.