Product Verification Engineer

Job Description:

Fluke Biomedical is seeking a skilled and dedicated Product Verification Engineer to join our engineering team. The V&V Engineer will be responsible for ensuring the design and development of medical devices meet all required regulatory, safety, and quality standards. This role will involve hands-on testing, analysis, and reporting to ensure our products are reliable, safe, and meet the highest industry standards.

Products will include low voltage AC and DC signal sources, High voltage measurement circuits, High current resistance measurement circuits, impedance measurement circuits, Air Flow and Fluid Flow measurement devices, Air Pressure measurement, and temperature simulations. The V&V Engineer will interact with systems that simulation the physiological outputs of the human body and utilize various hospital equipment (Patient Monitors, defibrillators, ventilators, etc.) along with test equipment (Digital Multi-meters, Oscilloscopes, signal generators, current and power supplies, etc.)

As a V&V Engineer, you will collaborate closely with design engineers, project managers, and regulatory teams to plan and execute testing activities, ensuring compliance with FDA, ISO, and other relevant standards. You will work within cross-functional teams to ensure the verification and validation processes support product development from concept through post-market.

Key Responsibilities:

Test Planning and Execution: Develop and execute verification and validation test plans, protocols, and procedures for medical device products to confirm compliance with regulatory standards and functional requirements. Documentation and Reporting: Create and maintain detailed documentation of test plans, results, deviations, and risk assessments. Generate reports and support the generation of technical files for regulatory submissions. Risk Management: Identify and assess potential risks, ensuring that proper mitigation strategies are in place. Ensure that V&V activities align with risk management requirements. Cross-Functional Collaboration: Work closely with cross-functional teams, including design engineers, regulatory affairs, and manufacturing, to define V&V needs and ensure timely delivery of test results. Root Cause Analysis and Troubleshooting: When issues arise, work with the engineering team to identify the root cause and support the resolution of any technical challenges. Regulatory Compliance: Ensure products are developed in accordance with FDA, ISO, IEC, and other applicable regulatory standards. Support regulatory audits and inspections as required. Continuous Improvement: Contribute to process improvements within the V&V activities and advocate for best practices in test design and execution.

Qualifications:

Experience:

Minimum of 7 years of experience in verification and validation, particularly in the medical device industry. Experience with the design, development, and validation of electrical, mechanical, and/or software systems in a regulated environment.

Skills & Knowledge:

Strong understanding of V&V methodologies, test case creation, execution, and documentation. Experience with test equipment such as oscilloscopes, multimeters, and function generators. Proficiency in using V&V tools and systems for test management and data analysis. Experience with root cause analysis, troubleshooting, and failure investigation. Excellent written and verbal communication skills to create clear reports and present findings.

Preferred Qualifications:

Education: Bachelor’s degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field. Experience working with automated testing systems. Experience in continuous improvement initiatives and process optimization. Familiarity with medical device regulations, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and other relevant standards.

Physical Requirements:

Ability to work in a laboratory setting, working with test equipment, and handling devices during verification and validation procedures.

Fortive Corporation Overview

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