Test Engineer

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.
Responsibilities:

• 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.

Requirements:

• 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.
• bility 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.

T op 3 must haves are:

• Strong analytical and problem-solving skills.
• Technical proficiency with testing tools and methodologies.
• Excellent communication and collaboration skills.