Verification & Validation Test Engineer

DEKA Research & Development
Manchester
Workplace: OnsiteFull timeFunction: QA, Test & Release EngineeringExperience: 3+ yearsEducation: bachelorsSkills: ["Leadership","Mentoring","Problem solving","Self-motivation","Interdisciplinary teamwork"]

Create verification and validation test plans, procedures, and reports to assess medical device performance, durability, and reliability. Develop test methods by understanding device design and core technologies, determine test coverage for design revisions, and evaluate fixtures for product design verification. Lead and support investigations tied to design failures, risk assessment, hazard analysis, and FTAs, and contribute to regulatory submissions and quality planning documentation.

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DEKA Research & Development
DEKA Research & Development
2 days ago

Verification & Validation Test Engineer

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Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 9 hours agoStatus: Live
Reposted: similar role first listed 6 months ago

Job Summary

Create verification and validation test plans, procedures, and reports to assess medical device performance, durability, and reliability. Develop test methods by understanding device design and core technologies, determine test coverage for design revisions, and evaluate fixtures for product design verification. Lead and support investigations tied to design failures, risk assessment, hazard analysis, and FTAs, and contribute to regulatory submissions and quality planning documentation.
Location: Manchester
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering
Seniority: Mid level

Key Responsibilities

  • •Write test plans and test procedures covering performance, durability, and reliability assessments.
  • •Understand device design and core technologies to inform test method development.
  • •Determine test coverage for design revisions and evaluate test fixtures for product design verification.
  • •Contribute to design failure investigations impacting risk assessment, hazard analysis, and FTAs.
  • •Author Quality Plans and Test Summaries and participate in regulatory and agency submissions.

Key Requirements

  • •BS in Biomedical, Mechanical, Electrical, and/or Robotics/Automation Engineering.
  • •3+ years’ experience testing electro-mechanical devices (medical devices preferred).
  • •Laboratory/wet lab skills and experience.
  • •Fluid system handling experience.
  • •Excellent verbal and written communication skills, with ability to create and explain team objectives and procedures.
Experience:3+ yearsMedical devicesElectro-mechanical devices
Education:Bachelor's in Biomedical, Mechanical, Electrical, and/or Robotics/Automation Engineering
Skills:LeadershipMentoringProblem solvingSelf-motivationInterdisciplinary teamwork
Tech Stack:FDA Quality System Regulations (QSRs)ISO 13485Risk assessmentHazard analysisFailure analysis

Company Brief

DEKA Research & Development
DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.
Industry: Medical Devices
Company Size: Large (251 to 1,000 employees)
Growth: Established Company
Headquarters: Manchester, United States
Founded: 1982
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