Qualifications:

1-4 years experience

Qualifications (skills, knowledge & abilities):

Ø Must be a resident of the Rochester, NY area or be willing to commute daily to work fulltime onsite, no WFH

Ø Strong written and verbal skills; confident/comfortable making presentations to others

Ø Excellent problem-solving and trouble-shooting skills, requires some initiative and judgment

Ø Excellent organizational skills and attention to details

Ø Ability to work within constraints as well as to challenge constraints to support good design

Ø Familiar with design and requirements engineering for medical devices

Ø Familiar with applicable development processes

Ø Familiar with general laboratory equipment and proper operation of such following SOPs

Ø Technical ability to understand the mechanical, electrical and software components of a system

Ø Ability to carry out general biochemical laboratory procedures including handling of human blood/serum samples and reagents for testing purposes

Ø Knowledge of development environment tools like Serena Business Mashups, HP (ALM) Quality Center, Aligned Elements, and Microsoft Team Foundation Server a plus

Ø 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.

Ø 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

Ø Design new test procedures for new features and functionality

Ø Develop self and always maintain knowledge in hardware test engineering field

Ø Participate in the execution, analysis, and reporting of subsystem and system testing

Ø Willingness to work in FDA/EU regulated medical devices environment utilizing defined processes and best practices

Ø Develop and execute verification and validation activities

Ø Execute test procedures, record, and later follow-up anomalies found during testing

Ø Communicate Test development and Execution status to Team Leader

Ø Perform other duties and projects as assigned