Hardware Verification and Validation Engineer

Qualifications: 1-4 years experience Qualifications (skills, knowledge & abilities): Must be a resident of the Rochester, NY area or be willing to commute daily to work fulltime onsite, no WFH Strong written and verbal skills; confident/comfortable making presentations to others Excellent problem-solving and trouble-shooting skills, requires some initiative and judgment Excellent organizational skills and attention to details Ability to work within constraints as well as to challenge constraints to support good design Familiar with design and requirements engineering for medical devices Familiar with applicable development processes Familiar with general laboratory equipment and proper operation of such following SOPs Technical ability to understand the mechanical, electrical and software components of a system Ability to carry out general biochemical laboratory procedures including handling of human blood/serum samples and reagents for testing purposes Knowledge of development environment tools like Serena Business Mashups, Client (ALM) Quality Center, Aligned Elements, and Microsoft Team Foundation Server a plus Experience with Jira, Windchill and Quality Center a plus These qualifications are typically associated with a minimum education of Bachelors Systems Engineering, Mechanical Engineering, Electrical Engineering or equivalent. Experience with any analyzers - especially family of Vitros Systems is a plus. Responsibilities: Major Job Functions: Perform hardware verification and validation testing, independently and/or, on multi-disciplined teams throughout the equipment/instrument development life cycle process. Apply system engineering methods for design and analysis, design verification, subsystem validation, and post launch product support. Work independently and as a team member to plan, write, and execute test cases according to client Quality Management System, FDA regulations, and ISO standards Design new test procedures for new features and functionality Develop self and always maintain knowledge in hardware test engineering field Participate in the execution, analysis, and reporting of subsystem and system testing Willingness to work in FDA/EU regulated medical devices environment utilizing defined processes and best practices Develop and execute verification and validation activities Execute test procedures, record, and later follow-up anomalies found during testing Communicate Test development and Execution status to Team Leader Perform other duties and projects as assigned