Principal Quality Engineer, Redwood City, CA - Perform Quality Assurance activities ranging from product development through transfer to manufacturing for implantable medical devices and accessories. Support new product development projects ensuring compliance to process/procedures related to design and development, risk management, and external standards on topics including biocompatibility, human factors and sterilization. Guide product development and ensure best engineering practices compliant with relevant regulatory requirements. Assess when medical device change/modification/project is subject to formal design control process. Review new/modified products ensuring test plans and test procedures demonstrated design/process conformance. Ensure compliance to applicable standards like 21CFR Part 820, ISO13485, and AIMDD. Participate on Project Teams by providing input on adequacy of engineering approaches selected and device product designs. Assess qualification and management of external suppliers in manufacturing. Develop and conduct biocompatibility device assessments for new product development and support revalidation for sustaining biocompatibility projects (ISO10993). Determine device sterilization requirements and ensure method and associated packaging are validated (ISO11135, ASTM D4169, ISO 11607). Support labeling review and approval (ISO 15223). Develop effective application, compliance and continuous improvement of policies, procedures and practices related to: Design Control Documentation; Product specification and Device Master Record; Design Verification & Validation activities; Human Factors evaluations; Risk Management; CAPA /NCMR/ HHEs; internal and external Regulatory Audits. Direct product development teams through completion of design control phases: Input, Output, Verification, Clinical Readiness, Validation, and Market Release. Support design transfer activities, reviewing test method validation, process and tools validations, application of lean six sigma tools, Design of Experiments. Support supplier identification for new products and conduct supplier qualifications and audits. Review and approve documentation deliverables associated with each design control phase. Identify potential hazards associated with device design, estimate/evaluate/control associated risks. Maintain Risk Management File including Risk Management Plan, Risk Analysis & Evaluation Worksheet, Risk Management Report. Conduct FMEA evaluations of products considering device use, design, and process (ISO14971). Examine information sources for hazards or product deficiencies and address via CAPA system. Complete projects by representing Quality Assurance. Execute elements of Design Control Improvement Plan and Risk Management Improvement Plan. Work with departments to discuss system gaps, fixes, design solutions and risks using Quality auditing, CAPA. Provide concise updates of critical projects to senior management. Remote work permitted at employer’s discretion. (No agencies or phone calls please.) #LI-DNI
Remote work is permitted at the employer’s discretion.