Senior System and Test Engineer
a day ago
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OnsiteFull-timeSenior
Summary
Full Spectrum is seeking a Senior System and Test Engineer to join their team in Westborough, MA. The role involves requirements development, integration, analysis, and verification of complex systems in a regulated environment.
About the Role
As a Senior System and Test Engineer, you will be responsible for requirements development, management, safety risk analysis, interface analysis, compliance engineering, and verification/validation (V&V) strategy. You will work closely with clients to translate user needs into technical requirements and ensure compliance with FDA standards. Your role will also include test case development and contributing to process improvement initiatives.
About You
Required:
- Experience in traditional system engineering practices including requirements elicitation.
- Knowledge of safety risk analysis for complex medical devices.
- Familiarity with FDA regulations and standards for medical devices.
Preferred:
- Bachelor’s Degree in Software, Electrical, or Computer Engineering or related science discipline; advanced degree is a plus.
- Experience in software quality engineering and computer system validation in a regulated environment.
- Familiarity with IEC 13485, ISO 14971, and other relevant standards.
Benefits
- Opportunity to work on cutting-edge engineering projects.
- Collaborative and innovative work environment.
- Professional development and learning opportunities.
Full Spectrum
Full Spectrum offers complete product development and testing services for Medical Device, Life Sciences, Evolving Healthcare , and Regulated Robotics. We have successfully completed over 1,000 development programs in our 40+ year history, including class III medical devices, highly efficient robotics, complex algorithm based systems and more.. ⦁ ISO 13485 certified since 2009 ⦁ Successfully in business since 1982
Westborough, MA