Test Engineer

VAPOTHERM, INC.•Fairfield, OH

13d

About The Position

The Test Engineer plans, executes, analyzes, and documents verification and validation activities supporting design, post-market, and sustaining engineering projects for medical devices. The role helps ensure product changes maintain safety, performance, reliability, and regulatory compliance throughout the product lifecycle. The engineer partners with R&D, Manufacturing Engineering, Quality, Regulatory Affairs, Supply Chain, and Operations to evaluate design modifications, component substitutions, supplier changes, manufacturing transfers, cost-reduction initiatives, and corrective actions. The position involves applying design controls, risk management, and medical device regulatory requirements, as well as hands-on laboratory testing, test method development, and continuous product improvement in a regulated environment.

Requirements

Bachelor of Science degree in Engineering or Biomedical Engineering preferred, or equivalent work experience.
2–5 years of engineering experience in medical device development, verification, validation, testing, or sustaining engineering.
Understanding of Design Controls and product development processes.
Knowledge of FDA and ISO medical device regulations.
Strong laboratory and hands-on testing skills.
Ability to interpret engineering drawings, specifications, and requirements.
Experience with root-cause investigations and problem-solving methodologies.
Familiarity with statistical analysis and data interpretation.
Strong technical writing and documentation skills.
Proficiency with Microsoft Office applications, including Excel and Word.
Excellent communication and cross-functional collaboration skills.
Ability to travel within the United States and internationally 20% of the time.

Nice To Haves

Experience with automated test equipment and data acquisition systems.
Familiarity with statistical software such as Minitab or JMP.
Knowledge of respiratory, infusion, monitoring, diagnostic, or disposable medical devices.

Responsibilities

Develop, execute, and document Design Verification and Validation (V&V) activities for R&D and sustaining engineering projects.
Create protocols and reports in compliance with FDA, ISO 13485, and internal Design Control procedures.
Verify that product changes continue to meet functional, performance, safety, usability, and reliability requirements.
Support validation activities related to design modifications, material substitutions, alternate supplier qualifications, component obsolescence mitigation, manufacturing process changes, cost-reduction initiatives, manufacturing transfers, and new designs.
Perform hands-on testing of medical devices, accessories, and disposables.
Develop and maintain test methods, fixtures, and equipment for product evaluations.
Conduct performance, environmental, reliability, and stress testing.
Analyze failures and identify root causes using structured problem-solving techniques.
Generate technical conclusions and recommendations based on data.
Support Design Control activities throughout the product lifecycle.
Ensure test activities comply with FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC, and other applicable product standards.
Support risk assessments and risk-control verification activities.
Participate in design reviews and change-control assessments.
Support Engineering Change Orders (ECOs) and Design Change Orders (DCOs).
Evaluate the impact of proposed product, process, and supplier changes.
Collaborate with cross-functional teams to define testing strategies for implementing changes.
Provide technical support for product investigations and field issues.
Support CAPA, complaint investigations, nonconformance investigations, and product performance assessments.
Assist in identifying root causes and verifying the effectiveness of corrective actions.
Maintain complete and accurate technical documentation within the Quality Management System.
Improve testing efficiency through fixture development, automation, and process improvements.
Recommend product enhancements based on testing results, field feedback, and reliability data.
Support laboratory equipment qualification, calibration, and preventive maintenance activities.