Systems Verification Engineer

Qualifications

• 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

Required Qualification

• Bachelors degree in electrical, Computer, Biotechnology, Systems Engineering, or other related field.
• 5+ 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.

Preferred Qualifications

• 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 working with 3D design tool, Creo , Solid works , Fusion 3Detc.
• Experience with low fidelity prototyping – 3d Printing, PCB design, PCB reworks etc.
• 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