Validation/Verification Engineer - Medical Devices at Sumeru Inc
Marlborough, Massachusetts, USA -
Full Time


Start Date

Immediate

Expiry Date

14 Nov, 25

Salary

90.0

Posted On

14 Aug, 25

Experience

1 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Requirement Specifications, Test Engineering, Troubleshooting, Software

Industry

Electrical/Electronic Manufacturing

Description

POSITION OVERVIEW

We are seeking a highly skilled and experienced Senior Test Engineer to lead complex engineering and troubleshooting initiatives across electrical, mechanical, and software systems. This role demands deep technical expertise, hands-on problem-solving skills, and strong cross-functional collaboration with internal teams and external suppliers. The ideal candidate will also possess expertise in validation processes and FDA Design Controls while serving as a technical mentor to peers.

REQUIRED QUALIFICATIONS

· Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, Software, or related field).
· 10+ years of hands-on experience in test engineering and troubleshooting.
· Strong understanding of FDA Design Controls and validation processes.
· Proven experience in 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.
Job Type: Contract
Pay: $90.00 per hour
Expected hours: 40 per week

Application Question(s):

  • This role is in Marlborough, MA, that pays $90/Hour Would you be able to relocate once offered? YES/NO

Experience:

  • FDA Design Controls : 1 year (Required)
  • User Requirement Specifications (URS): 1 year (Required)
  • Validation Protocols: 1 year (Required)

Ability to Commute:

  • Marlborough, MA (Required)

Work Location: Remot

Responsibilities

· Lead and execute test engineering activities across electrical, mechanical, and software domains.
· Troubleshoot complex system issues; drive resolution through root cause analysis and cross-functional teamwork.
· Collaborate 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 execute validation protocols, including hardware/software validation and User Requirement Specifications (URS).
· Provide technical mentorship and guidance to junior engineers and peers.
· Partner with internal teams to ensure alignment on design and testing requirements.
· Thoroughly document test processes, equipment, and results.

Loading...