Sr Design Assurance Engineer
Physio-Control, Inc. - Redmond, WA

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Interface with product development teams and coordinate design assurance activities over the entire development lifecycle for new product and technology development programs, as well as change projects. Plan, develop, execute and document design assurance programs, including verification, for assigned projects. Work collaboratively with development teams to identify and appropriately address design quality and reliability issues during development. Ensure compliance with all applicable Quality System requirements and the proper utilization of established best practices related to product design assurance. Produce complete, concise, clear and technically correct work outputs. Actively participate in and contribute to improvements to design assurance processes and tools.

• Manage and execute design verification activities for assigned development programs and ensure compliance with applicable Quality System requirements:
o Review and modify product design inputs for completeness, adequacy and testability
o Develop product design verification plans and design verification protocols
o Coordinate verification executions and resolution of issues
o Conduct statistical analysis of verification results and create verification reports
• Manage and execute design assurance activities for assigned development programs and ensure application of best practices:
o Review and modify product design inputs for completeness, adequacy and testability
o Develop product design assurance program plans
o Coordinate product design assurance assessments, including tests and analysis
• Participate in design assurance improvement initiatives, and provide technical contributions for the evolution of design assurance best practices
• Work with limited supervision, and provide mentorship for other design assurance team members
• Bachelor’s degree in electrical or mechanical engineering, computer science or related discipline
• 5 years of design assurance or equivalent experience in a product development environment
• Solid knowledge of design assurance techniques and statistical tools
• Excellent technical writing skills and strong interpersonal communication skills
• Demonstrated ability to manage complex projects and multiple priorities
• Working knowledge of design and project management methodologies
• Masters degree and more than 5 years of related experience
• Experience in an externally regulated product development environment (FDA, FAA, etc.)
• Familiarity with 21 CFR 820 regulations and ISO 13485, and 17025 medical device standards
• Experience with AAMI and IEC product standards, and agency (UL, CSA, TUV) certification
• Both Office and Lab environments, extended hours as needed

Physio-Control, Inc. - 21 months ago - save job