FDA Hardware Validation Engineer (ONSITE)

Netsource - Rochester, NY

Full-time - Entry Level

Rochester, NY

Professional, Scientific, and Technical Services

About the position

The FDA Hardware Validation Engineer will be responsible for performing hardware verification and validation testing for medical devices in a regulated environment. This role requires strong problem-solving skills, attention to detail, and the ability to work both independently and as part of a team. The engineer will apply system engineering methods throughout the equipment development life cycle, ensuring compliance with FDA regulations and ISO standards.

Responsibilities

• Perform hardware verification and validation testing independently and 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 maintain knowledge in the 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 follow up on anomalies found during testing.
• Communicate test development and execution status to Team Leader.
• Perform other duties and projects as assigned.

Requirements

• Strong written and verbal skills; confident/comfortable making presentations to others.
• Excellent problem-solving and troubleshooting skills, requiring initiative and judgment.
• Excellent organizational skills and attention to detail.
• Ability to work within constraints and challenge them to support good design.
• Familiarity with design and requirements engineering for medical devices.
• Familiarity with applicable development processes.
• Familiarity with general laboratory equipment and proper operation 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 human blood/serum samples and reagents for testing purposes.
• Knowledge of development environment tools like Serena Business Mashups, HP (ALM) Quality Center, Aligned Elements, and Microsoft Team Foundation Server is a plus.
• Experience with Jira, Windchill, and Quality Center is a plus.

Nice-to-haves

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