Abbott Sr. Manager System Integration , V&V in Santa Clara, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Sr. Manager Systems Engineering – V&V will be hands-on and direct the R&D Systems Verification & Validation organization responsible for developing and launching complex electromechanical hematology analyzers. The System Verification & Validation team defines and implements the system V&V strategy and methods related to regulatory requirements and internal quality standards.
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
Minimum Qualifications :
Four-year degree in technical or scientific discipline (Post graduate degree preferred).
Eight plus years’ industry experience, at least three in a managerial or supervisory role.
Experience with complex systems development, architecture, software or system integration.
Understands engineering standards, FDA regulation, performance confirmation methods and development practices within Abbott, or in a comparable environment outside of Abbott.
Must have project management experience including managing multiple projects
Bachelor degree in engineering or science and a minimum of 10 years of experience in the integration, verification and validation of complex IVD systems; Master’s/PhD degree preferred.
People Management experience of 3+ years required with demonstrated ability to coach, mentor, and develop; prior management experience in GLP or clinical/hospital labs a plus.
Outstanding communication, influence, and conflict resolution skills.
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).
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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