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
$1 - $2
Mar 12, 2018