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Sr Test Engineer

Three Point Solutions, Inc.

  • Lafayette, CO
  • 1 day ago
  • $50–$55 Per Hour
  • Contractor

Highlights

Responsible for verification planning, test method development/validation, test execution, technical analysis, and regulatory-ready documentation while working with cross-functional R&D teams. Lead system verification and validation (V&V) activities for Interventional medical device products.

Numbers & Facts

LocationLafayette, CO
Job TypeContractor
Salary$50–$55 Per Hour

Description

Job Title: Sr Test Engineer

Client: Medical Device Manufacturing Company

Duration: 12 Months Contract

Location: Lafayette, CO 80026

Job Summary

Lead system verification and validation (V&V) activities for Interventional medical device products. Responsible for verification planning, test method development/validation, test execution, technical analysis, and regulatory-ready documentation while working with cross-functional R&D teams.

Job Responsibilities

Key Responsibilities

  • Develop verification plans, protocols, sample-size justifications, and acceptance criteria.
  • Lead design-input verification for sterilized disposable instruments.
  • Develop and validate test methods, plans, and validation reports.
  • Execute system-level verification testing and document results.
  • Prepare regulatory submission-ready engineering reports.
  • Support design validation using real users in simulated or actual-use environments.
  • Support design reviews, risk management, and system-level validation.
  • Collaborate with Systems, Mechanical, Electrical, Quality, Manufacturing, Marketing, Human Factors, and Regulatory teams.
  • Perform minimally invasive therapy/product testing in soft tissue according to applicable standards.
  • Analyze test results and communicate findings, conclusions, and recommendations.
  • Provide technical leadership to engineers and external development partners.
  • Support V&V activities throughout the product development lifecycle.

Qualifications

Required Qualifications

  • Bachelor’s degree in Engineering/Science + 6+ years technical testing or engineering experience; OR
  • Advanced degree + 4+ years relevant experience.
  • Experience leading system-level verification and validation planning, execution, and documentation.
  • Experience with ex-vivo tissue testing.
  • Basic mechanical and electrical engineering knowledge.
  • Experience with test equipment such as Instron and multimeters.
  • Ability to work independently and cross-functionally.
  • Strong organization, prioritization, communication, and technical reporting skills.


Preferred Qualifications

  • Medical device, aerospace, defense, or other regulated industry experience.
  • Knowledge of IEC 60601, electrical safety, and EMC testing.
  • Design for Reliability/Manufacturability and Six Sigma knowledge.
  • Experience tracing system design inputs through test results.
  • Experience with systems combining mechanical, electrical, and software components.
  • Experience owning systems-engineering execution across the full V-model lifecycle.

Top 3 Technical Skills

  • V&V Strategy & Leadership
  • Test Method Development & Validation
  • Test Execution & Regulatory Documentation

About Company

Medical Device Manufacturing Company

 

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