R&D V&V Engineer, Orthopedics

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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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

Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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

We are searching for the best talent for R&D V&V Engineer in Warsaw, Indiana

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, while also supporting the lifecycle of released products. You will work with systems, software, hardware, support, and quality teams to plan, develop, and complete verification, validation, and lifecycle management activities in compliance with FDA, ISO 13485, and other applicable regulatory standards.

The responsibilities & the impact YOU will have:

• Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs through verification and validation.
• Define minimum testable requirements following a change, based on risk, essential performance, and basic safety.
• Develop and implement 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 across investigational, integration, reliability, and formal V&V testing.
• Prepare and deliver system-level V&V documentation, including summary reports and verification results.
• Review and approve subsystem verification work to ensure alignment with overall system requirements.
• Design, validate, and implement test methods, including manual and automated test setups, to verify product requirements and demonstrate repeatability and reproducibility.
• Ensure compliance with regulatory standards, including FDA 21 CFR Part 820, ISO 13485, IEC 60601, and ISO 14971.
• Support design transfer and product launch activities, including complaint investigations.
• Investigate and document nonconformances, deviations, and test failures; drive root cause analysis and corrective actions.
• Collaborate with Regulatory, Quality, and Manufacturing teams to support audits and inspections.
• Partner with Support and Development teams to investigate field issues and customer complaints.
• Support post-market surveillance activities by providing technical analysis, product documentation, and investigation support.
• Assist with maintaining regulatory documentation.
• Assist with handling obsolescence and technology upgrades.
• Support continued product compliance with regulations, standards, approved procedures, and requirements throughout the product lifecycle.
• Coordinate testing with partners across R&D, Quality, Regulatory, Production, and Supply Chain.
• Communicate business-related issues or opportunities to the next management level.
• Follow all Company guidelines related to Health, Safety, and Environmental practices, as applicable.
• Ensure personal and Company compliance with all federal, state, local, and Company regulations, policies, and procedures.
• Fulfill other V&V testing needs as assigned.

Qualifications

• Education: Bachelor’s degree or equivalent in Mechanical, Biomedical, Systems, Electrical Engineering, or a related field.
• 3+ years of V&V engineering experience 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 helpful
• Strong understanding of systems engineering principles and the product development lifecycle, including V-model, waterfall, and Agile methodologies.
• Experience with requirements management tools such as DOORS, Jama, or Polarion.
• Familiarity with test automation tools and scripting languages such as Python, LabVIEW, or MATLAB.
• Excellent technical writing and communication skills.
• Certification as a CQE or CQA, or a Six Sigma certification, 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.

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