Duration: 12 months to start

Job Description

• We are seeking a highly skilled and experienced Senior Test Engineer to support and lead complex engineering and troubleshooting efforts across electrical, mechanical, and software systems.
• This individual contributor role requires deep technical knowledge, hands-on problem-solving ability, and strong collaboration skills to work effectively with internal teams and external suppliers.
• The ideal candidate will also bring expertise in validation processes and FDA Design Controls, and serve as a technical mentor within the organization.

• Lead and execute test engineering activities across electrical, mechanical, and software domains.
• Troubleshoot complex system issues and drive resolution through root cause analysis and cross-functional collaboration.
• Interface with external suppliers to ensure quality, compliance, and timely delivery of components and systems.
• Develop and maintain documentation in alignment with FDA Design Controls, including design inputs, outputs, and traceability.
• Create and support validation protocols, including software/hardware validation and URS (User Requirement Specifications).
• Provide technical mentorship and guidance to peers and junior engineers.
• Collaborate with internal stakeholders to ensure alignment on design and testing requirements.
• Document equipment and test processes thoroughly and accurately.

• Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, Software, or related field).
• Minimum of 10 years of hands-on experience in test engineering and troubleshooting.
• Strong understanding of FDA Design Controls and validation processes.
• Proven experience working with and managing technical aspects of external suppliers.
• Demonstrated ability to create URS and execute validation protocols.
• Excellent problem-solving, communication, and organizational skills.
• Ability to lead through technical expertise and mentorship, without direct reports.

• Experience in medical device or other regulated industries.
• Familiarity with ISO standards and regulatory compliance.
• Experience with documentation systems and quality management tools.