Product Verification Engineer

FortiveEverett, WA
3d

About The Position

Product verification Engineer As part of a passionate, and accomplished team of experts, you will work on Biomed test Equipment’s Radiation and Dosimetry systems. You will support the design, development, and verification of complex electromechanical systems by working across subsystems. You will create, manage, and verify product requirements and develop test and development infrastructures for automation and regression verification. This position will have a direct impact on the design of test equipment used by healthcare industries to save lives daily, and will require your dedicated commitment and detailed attention have safe and repeatable medical services. We are looking for someone who will use their technical knowledge and commitment to quality to improve people's lives through safer medical services.

Requirements

  • Bachelor’s degree in electrical, Computer, Biotechnology, Systems Engineering, or other related field.
  • 3+ years’ experience in electromechanical device and system design/verification for new product development
  • Direct hands-on systems engineering experience, preferably with medical device electronic systems or other complex electronic hardware.
  • Technical competencies: Experience developing software driven electromechanical devices in a regulated environment.
  • Broad engineering expertise across all engineering disciplines.
  • Direct experience in requirements authoring, decomposition, analysis, traceability, and verification.
  • Direct experience with complex electronics systems/component design.
  • Experience in writing detailed product Verification/qualification plans and reports.
  • Experience with integrated systems verification, including developing hardware verification test plans and verification test reports.
  • Previous experience with change management
  • Hands-on experience building, testing, and troubleshooting prototype devices
  • Ability to manage and prioritize workload, multi-task and manage a diverse mix of issues, responsibilities, and challenge.

Nice To Haves

  • Familiarity with all phases of the product development lifecycle.
  • Familiarity with HW / Embedded SW development, integration, and verification
  • Familiarity with scripting and data analysis experience using Python, MATLAB, or equivalent programming languages.
  • Experience in the medical device industry, ISO 13845 , FDA quality management system
  • Enjoy working effectively as part of a small, fast-paced, cross-functional, cross-cultural integrated team

Responsibilities

  • Create and maintain requirements and specifications for existing and new products.
  • Draft and update product requirements and verification documentation based on marketing and engineering inputs
  • Coordinate and complete product design reviews.
  • create clear product design documentation such as concept diagrams, specifications, requirements, test plans, and V&V reports
  • perform test/verification for NPI or sustaining of innovative electromechanical products
  • Establish and maintain traceability between requirements, and testing
  • Develop test protocols for the purposes of design verification and validation
  • Execute testing and generate associated reports
  • Oversee the building and testing of prototypes, including internal team and external vendor management
  • Performs hands-on system testing and troubleshooting of technical issues
  • Design benchtop tests, fixtures, and regression test plans to prove out concepts, functionality, and safety
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