Job Title: Hardware Verification and Validation Engineer
Location: Rochester, NY
Duration: 24 months
Job Description:
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 ********* 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
Quals--
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.