Job Description
Job Description
Job Title: Sr Test Engineer
Client: Medical Device Manufacturing Company
Duration: 12 Months – Possibility of Extension
Location: Lafayette, CO 80026
Shift: 1st Shift
Description:
Job Summary
The Sr Test Engineer will support system verification and validation (V&V) for Interventional products within an R&D environment. The role leads verification planning, test method development and validation, execution, and regulatory-ready documentation while partnering with Systems Engineering, Design, Quality, Manufacturing, Marketing, Human Factors, and Regulatory teams.
The ideal candidate can work independently from high-level scope and constraints and provide senior-level technical leadership throughout the product development cycle.
Top 3 Technical Skills
- Verification & Validation Strategy Leadership
- Test Method Development & Validation
- Execution Discipline & Regulatory Documentation
Key Responsibilities
- Develop comprehensive verification testing plans, including test method validation.
- Create verification protocols with sample-size justifications and acceptance criteria.
- Lead design-input verification for sterilized disposable instruments, including system compatibility, reliability, mechanical performance, and tissue performance.
- Develop test methods, test method validation plans, and validation reports.
- Build and document verification evidence through regulatory submission-ready engineering reports.
- Support design validation of user needs with real end-users in real or simulated-use environments.
- Support design reviews and risk management activities.
- Partner with Systems, Mechanical, Electrical, Design Quality, and laboratory teams throughout V&V activities.
- Work with Manufacturing, Quality, Marketing, Human Factors, and Regulatory teams to ensure designs are verified in compliance with medical device standards.
- Execute minimally invasive therapy procedures and product testing in soft tissue according to applicable standards and internal procedures.
- Analyze and communicate test findings, conclusions, and recommendations to cross-functional teams.
- Provide senior-level technical leadership to internal engineers and external development partners.
- Support system-level validation planning, execution, and documentation.
Required Qualifications
- Bachelor’s degree in Engineering or a scientific discipline with 6+ years of technical testing or engineering experience, OR
- Advanced degree in Engineering or a scientific discipline with 4+ years of technical testing or engineering experience.
- Experience leading system-level verification planning, execution, and documentation.
- Experience supporting system-level validation planning, execution, and documentation.
- Experience testing devices in ex-vivo tissue.
- Basic knowledge of mechanical and electrical engineering fundamentals.
- Basic knowledge of mechanical and electrical test equipment, such as Instron and multimeters.
- Ability to work independently and effectively within a cross-functional team environment.
- Strong organizational, prioritization, and communication skills.
Preferred Qualifications
- Experience working in a regulated industry, such as medical, aerospace, or defense.
- Knowledge of IEC 60601 testing standards.
- Knowledge of electrical safety and EMC testing.
- Familiarity with Design for Reliability and Manufacturability (DRM) and Six Sigma practices.
- Experience tracing system design inputs through test results.
- Experience working with systems containing mechanical, electrical, and software elements.
- Experience owning systems-engineering execution across the full V-model lifecycle.
Key Skills
- Verification & Validation (V&V)
- Test Method Development
- Test Method Validation
- System-Level Testing
- Regulatory Documentation
- Design Verification & Validation
- Risk Management
- Medical Device Testing
- Mechanical & Electrical Testing
- Ex-Vivo Tissue Testing
- IEC 60601
- EMC & Electrical Safety Testing
- Six Sigma / DRM
- Cross-Functional Leadership
- Technical Reporting
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\nCompany Description
As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.
Company Description
As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.