SUMMARY OF POSITION
The Test Engineer, plans, executes, analyzes, and documents verification and validation activities that support design, post-market and sustaining engineering projects for medical devices. This role ensures product changes maintain safety, performance, reliability, and regulatory compliance throughout the product lifecycle.
The engineer will partner closely with R&D, Manufacturing Engineering, Quality, Regulatory Affairs, Supply Chain, and Operations teams to evaluate design modifications, component substitutions, supplier changes, manufacturing transfers, cost reduction initiatives, and corrective actions. The position requires understanding of design controls, risk management, and medical device regulatory requirements.
This role is ideal for an engineer with hands-on laboratory experience who enjoys solving technical problems, developing test methods, and supporting continuous product improvement in a regulated environment.
PRIMARY RESPONSIBILITIES
Verification & Validation Support
- 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
- New Designs
Product Testing
- Perform hands-on testing of medical devices, accessories, and disposables.
- Develop and maintain test methods, fixtures, and equipment necessary to support 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.
Design Controls & Regulatory Compliance
Support Design Control activities throughout the product lifecycle.
Ensure test activities maintain compliance 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.
Sustaining Engineering Projects
- Support Engineering Change Orders (ECOs) and Design Change Orders (DCOs).
- Evaluate impact of proposed product, process, and supplier changes.
- Collaborate with cross-functional teams to define testing strategies for implementation of changes.
- Provide technical support for product investigations and field issues.
Quality System Activities
- 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.
Continuous Improvement
- Improve testing efficiency through fixture development, automation, and process improvements.
- Recommend enhancements to products based on testing results, field feedback, and reliability data.
- Support laboratory equipment qualification, calibration, and preventive maintenance activities.
POSITION REQUIREMENTS
- B.S. Degree in Engineering or BioMed preferred or equivalent work experience.
- Minimum of 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.
- Able to travel within US and internationally 20% of the time
Preferred Qualifications
- 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.