Nesco Resource - Rochester, NY

posted 14 days ago

Full-time - Entry Level
Rochester, NY
Administrative and Support Services

About the position

The Hardware Verification and Validation Engineer will be responsible for performing hardware testing in a regulated medical devices environment. This role involves both independent and collaborative work throughout the equipment development lifecycle, ensuring compliance with quality management systems and regulatory standards.

Responsibilities

  • Perform hardware verification and validation testing independently and as part of a multi-disciplinary team throughout the equipment/instrument development lifecycle.
  • Apply systems engineering methods for design analysis, design verification, subsystem validation, and post-launch product support.
  • Plan, write, and execute test cases following quality management systems, FDA regulations, and ISO standards.
  • Design new test procedures for emerging features and functionalities.
  • Continuously develop knowledge and expertise in hardware test engineering.
  • Participate in the execution, analysis, and reporting of subsystem and system testing activities.
  • Work within an FDA/EU-regulated medical devices environment, adhering to established processes and best practices.
  • Develop and execute verification and validation activities for hardware components.
  • Document and track anomalies identified during testing and perform follow-up activities as necessary.
  • Provide regular updates on test development and execution status to the team leader.
  • Perform other related duties and projects as assigned.

Requirements

  • 1-4 years of relevant experience.
  • Must be a resident of the Rochester, NY area or willing to commute daily for full-time onsite work (no remote option).
  • Strong written and verbal communication skills, with the ability to confidently present findings.
  • Excellent problem-solving and troubleshooting skills, with the initiative and judgment to resolve complex issues.
  • Strong organizational skills and keen attention to detail.
  • Familiarity with design and requirements engineering for medical devices.
  • Understanding of applicable development processes and general laboratory equipment.
  • Ability to handle human blood/serum samples and reagents for testing in a biochemical laboratory setting.
  • Knowledge of tools such as Serena Business Mashups, Client (ALM) Quality Center, Aligned Elements, and Microsoft Team Foundation Server is a plus.
  • Experience with Jira, Windchill, and Quality Center is an advantage.

Nice-to-haves

  • Experience with analyzers, especially the Vitros® Systems family.

Benefits

  • MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
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