"Alerted.org

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Product Development

Job Sub** **Function:

R&D Software/Systems Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Warsaw, Indiana, United States of America

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

_An internal pre-identified candidate for consideration has been identified. However, all applications will be considered._

We are searching for the best talent for a **Systems V&V Engineer** to be in **Warsaw, IN** .

Job Summary

We are seeking a highly motivated **Verification & Validation (V&V) Systems Engineer** to join our medical device development team. In this role, you will be responsible for ensuring that our products meet all specified requirements and are safe and effective for their intended use. You will work cross-functionally with systems, software, hardware, and quality teams to plan, develop, and execute V&V activities in compliance with FDA, ISO 13485, and other applicable regulatory standards.

This position is under a Collective Bargaining Agreement in a union environment.

Duties & Responsibilities

+ Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs through verification and validation.

+ Define minimum testable requirements post-change (risk-based, essential performance, basic safety).

+ Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, including system verification protocols and regression plans that ensure robust requirements coverage; this includes investigational, integration, reliability, and formal V&V testing.

+ Prepare and deliver system-level V&V documentation, including summary reports and verification results.

+ Reviewing and approving sub-system verification deliverables to ensure alignment with overall system requirements.

+ Design, validate, and implement test methods, including manual and automated test setups, to ensure they are suitable for verifying product requirements, including repeatability, reproducibility.

+ Oversee the maintenance of robotics test lab facilities, ensuring all equipment and infrastructure are properly calibrated, serviced, and compliant with company safety, quality, and procedural standards; proactively identify and resolve issues to support uninterrupted testing and development workflows.

+ Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601, ISO 14971).

+ Support design transfer and product launch activities including complaints investigations.

+ Investigate and document non-conformances, deviations, and test failures; drive root cause analysis and corrective actions.

+ Interface with regulatory, quality, and manufacturing teams to support audits and inspections.

+ Responsible for communicating business related issues or opportunities to next management level.

+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

+ Performs other duties assigned as needed.

Qualifications

+ Bachelor’s or Master’s degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, or related field.

+ 3+ years of experience in V&V engineering within the medical device industry.

+ Experience with Class II or Class III medical devices is preferred.

+ Knowledge of embedded systems, firmware/software testing, or electromechanical systems is a plus.

+ Strong understanding of systems engineering principles and product development lifecycle (e.g., V-model, waterfall, Agile).

+ Experience with requirements management tools (e.g., DOORS, Jama, Polarion).

+ Familiarity with test automation tools and scripting languages (e.g., Python, LabVIEW, MATLAB).

+ Excellent technical writing and communication skills

+ Certification in CQE, CQA, or Six Sigma is a plus.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.