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Sr. Test and Design Assurance Engineer
Ref No.: 18-13266
Location: Minneapolis, Minnesota
Sr. Test and Design Assurance Engineer

We are seeking an experienced, high caliber software engineer to join our Software Verification team. The Senior Software Verification Engineer will bring software testing and design quality expertise to the verification team. This high caliber individual will have significant input into the day-to-day software testing activities and validation/qualification of testing tools/software/equipment. Requirements analysis, test design, test protocols, test execution, defect issue resolution, development of testing tool's specifications, work instructions, guidance and SOPs.

Responsibilities include:

• Work on software verification activities including requirements analysis, test design, test protocols, test execution, defect reporting and tracking.
• Provide verification and validation perspective to R&D's ongoing product development: requirements, product and test designs, defect reviews, user workflows, and field complaint investigations
• Validate/qualify test equipment/tools/software
• Develop Test Plans, Test Protocols, Tech reports, Check Lists, test equipment specifications, test methods, work instructions, guidance and SOPs
• Strong comprehension and demonstrated ability to apply critical regulatory standards to procedural updates and project deliverables
• Ability to handle multiple priorities and consistently meet deadlines through effective time management skills.
• Provide guidance and support for design verification activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
• Review, provide input and approve project-related deliverables and change orders.

Must Have Skills/Requirements:
• BA/BS in Engineering or Science related field.
• 5+ years engineering experience.
• 2-3 years of experience in the Quality Engineering/Design Assurance capacity in the medical device industry
• 3-5 years of professional software test engineering experience.