System  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

·         Bachelor’s 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.