2375 Sr. Manager Systems Engineering – V&V

Location: Northern San Jose area, CA
Job Type: Direct Hire
Salary: $1.00 - $2.00
Date: 3/12/2018
Job ID: 02569229
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 – 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
  • 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