2375 Sr. Manager Systems Engineering Â? V&V

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  • Northern San Jose area, CA United States
  • Mar 13, 2018
Full time

Job Description

Sr. Systems Engineering Manager-San Jose area CA Our client, a Fortune 150 Global Supplier of Specialty Medical Diagnostic Equipment manufacturer designing and launching next generation platform and accessories is looking for a Sr. Manager Systems Engineering â?? V&V who will be hands-on and direct the R&D Systems Verification & Validation organization responsible for developing and launching complex electromechanical diagnostic IVD equipment The System Verification & Validation team defines and implements the system V&V strategy and methods related to regulatory requirements and internal quality standards. Managing a team of 10 to include lab processes testing and EM test and verification Job Responsibilities: Manage the R&D laboratory and Verification & Validation teams. Possess a deep understanding of systems engineering methodologies supporting integration and experimentation as well as verification and validation; experience in GLP or clinical/hospital labs a plus. Lead the Verification and Validation strategy for system development projects in an FDA regulated environment that meet internal quality requirements and regulatory standards for Class II medical devices (ISO 9001/13485, FDA 21 DFR 820.30, ISO 14791, IEC 62304, CLSI). Perform a disciplined system engineering and analysis approach to the definition and execution of V&V plans, protocols, and reports including risk management mitigation. Apply fundamental understanding in statistical principles (ANOVA, F-test, DoE etc.) and statistical process control to design and conduct meaningful analytical experiments; show strong experience in the analysis and interpretation of data. Possess a strong background in common risk management techniques (FMEA, FTA) and CAPA, DMAIC etc. to develop best practices in integrated system development. Demonstrate cross-functional collaboration to ensure system and sub-system requirements are measurable, testable and meet quality system requirements. Demonstrate experience with DOORS, HP-ALM quality system preferred. Experience with test automation tools a plus; knowledge of DFSS (Green/Black Belt) preferred. Staff Management: communicating job expectations, planning, monitoring, and appraising job results, coaching and counseling employees, recognizing performance issues and driving improvement; enforcing compliance to policies, procedures, and standards Qualifications: Bachelor degree in engineering or science MS or MBA or PHd ideal 8-10 years of experience in the integration, verification and validation of complex IVD systems; with at least three in a managerial or supervisory role. Experience with complex systems development, architecture, software or system integration. Proven experience managing V&V projects in an FDA regulated environment; competent in the application of quality and regulatory standards (ISO 9001/13485, FDA 21 DFR 820.30, CLSI). Must have project management experience including managing multiple projects

Salary

$1 - $2

Degree

Mar 12, 2018

Job ID

90236