Job Description
We are seeking an experienced Senior Test Engineer to lead and execute complex testing and troubleshooting across electrical, mechanical, and software systems . This role demands deep technical expertise, strong problem-solving skills, and the ability to collaborate effectively with cross-functional teams and external suppliers.
Responsibilities:
- Bachelor’s/Master’s in Engineering with 10+ years of test engineering experience .
- Lead testing and validation activities across multiple engineering domains.
- Strong knowledge of FDA Design Controls, validation processes, and regulatory compliance.
- Proven experience working with external suppliers and executing URS/validation protocols.
- Medical device or regulated industry background preferred.
- Troubleshoot complex system issues and perform root cause analysis.
- Develop and maintain documentation per FDA Design Controls and regulatory standards .
- Create URS, validation protocols, and ensure supplier quality and compliance.
- Provide technical mentorship to peers and junior engineers.
Job Tags