Hardware Verification and Validation Engineer - Integrated Resources, Inc

 
 
  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.
  

 
 
  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