Sr. Manager, Systems Engineering, Diagnostics

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Location
Santa Clara, CA
Salary
$160,000 - $190,000
Job Type
Direct Hire
Date
Aug 14, 2018
Job ID
2597414
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The Sr. Systems Engineering Manager will be hands-on and applies a diversified knowledge of Requirements Definition, Configuration, Risk Management, Human Factors and Usability Engineering principles, practices, and implementation in the development of complex diagnostic systems. She/he drives requirements into system and subsystem definitions, supports the capture and tracking of technical risk parameters, and advises the team on the selection and deployment of appropriate tools and standards. The candidate will be an expert in the application of Rational DOORS Next Generation and configuration management tools.
 
Job Responsibilities:
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Manage within matrix environment Systems Engineering activities and lead the Definition of Requirements and the Integration of Compliance Engineering, Human Factors, Usability Engineering, Configuration and Risk Management through all phases of the system development lifecycle.
  • Facilitate cross-functional team discussions related to system requirements, system functional decomposition, requirements allocation, system architecture definition, system modeling, and requirements traceability and compliance.
  • Demonstrate strong systems engineering knowledge and expertise in the application of Rational DOORS Next Generation and Configuration Management tools.
  • Highlight design constraints and architectural limitations of design candidates to R&D team. Propose solutions to resolve challenges and realize product function.
  • Lead technical risk management during the development process. Compose risk management documents, including dFMEAs that comply with ISO standards (ISO 14971).
  • Create and maintain usability engineering files, including identification of use cases, creation of task list and uFMEA, extending to planning of formative and summative studies.
  • Define and design configuration management standards and establish CM infrastructure to automate major processes.
  • Apply Design Control / Design for Six Sigma including experimental and engineering investigation techniques (DMAIC).
  • Formulate impact summary to aid in understanding proposed changes to medical device regulations and standards (EU MDR, ISO 13485, IEC 60601, IEC 62366, ANSI/AAMI HE75, FDA QSR 820.30)
 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, and software or system integration. Understands engineering standards, FDA regulation, performance confirmation methods and development practices within the company, or in a comparable environment outside of the company. Must have project management experience including managing multiple projects.
  • BS in Engineering; MS preferred
  • 10+ years systems engineering experience within complex electromechanical systems; IVD products preferred
  • Strong knowledge on requirements data base tools and risk management processes, usability engineering, human factors, and configuration management infrastructure.
  • 5+ year’s management experience. Experienced leader who can define product development strategy, process and align resources across functions.
  • Strong knowledge of international standards and experience with international distributions (EU MDR, ISO 13485, IEC 60601, IEC 62366, ANSI/AAMI HE75, FDA QSR 820.30)
  • Knowledge of DFSS; Green Belt/Black Belt preferred
  • Proven ability to successfully drive on-time product launches for complex products
  • Must be comfortable working in a large matrixed organization following design controls 
Identifier: $MEDD. $NEER