R.A. Wylan & Co. Inc.,
Career Center

2376 Sr. Systems Engineering Manager

Location: Northern San Jose area, CA
Job Type: Direct Hire
Salary: $1.00 - $2.00
Date: 5/21/2018
Job ID: 02569233
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 Systems Engineering Manager to be hands-on and apply 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.
This Leader will determine and drive 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.
They need an expert in the application of Rational DOORS Next Generation and configuration management tools.
 

Job Responsibilities
  • 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
  • BS in Engineering; MS preferred
  • 10+ years systems engineering experience within complex electro-mechanical systems; IVD products preferred
  • Strong knowledge on requirements data base tools and risk management processes, usability engineering, human factors, and configuration management infrastructure.
  • 5+ years management experience. Experienced leader who can define product development strategy, process and align resources across functions.
  • Rational DOORS Next Generation and Configuration Management tools required
  • 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 
ABOVE AVERAGE SALARY + LUCRATIVE BONUS and LTI
FULL RELOCATION Package provided