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.