Design AssuranceEngineer

Position Title: Design Assurance Engineer

Work Location: Pleasanton, CA, USA, 94588

Assignment Duration: 6 months (possible extension)

Work Schedule: 6 AM to 2:30 PM

Position Summary:

Subject Matter Expert (SME) is responsible for developing and maintaining quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support.

A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system.

Key Responsibilities:

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  Lead design assurance activities in support of development for risk management files (Hazard Analysis, FMEA, Risk management Planning, Risk Management Report, Benefit Risk Analysis) per ISO 14971 guidelines.

  
  
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  Manage new risk management file

  
  
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  Work with Engineering, Marketing, Manufacturing and Regulatory to establish risk management files.

  
  
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  Understands test plan protocols, test procedures, and test reports used for risk controls.

  
  
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  Understand design verification and design validation plans and links to the risk management files.

  
  
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  Understands implication of risk management in Verification and Validation sampling plans.

  
  
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  Able to lead technical discussions of products and associated risk management documentation.

  
  

Qualification & Experience:

• SME for domestic/international sites and affiliates regarding Risk Management Quality System element. Works cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation.
• ?Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.
• Perform Health Hazard and Regulatory Risk Evaluations.
• Bachelors Degree ( 16 years) Engineering or Technical Field Experience Experience Details Both overall and any industry-specific experience needed: 5 years i. Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance. ii. Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred.
• Experience with risk management (ISO 14971) required. Knowledge of various tools and techniques for Risk Management is desirable. Knowledge of IEC60601-1 or electrical safety is desirable. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.