Product Verification Engineer

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

Fortive?s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential?your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

Fortive: For you, for us, for growth.

The salary range for this position (in local currency) is 65,100.00 - 120,900.00

We are an Equal Opportunity Employer

Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities.

Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.