Senior R&D V&V Engineer
7103-Orthotaxy Legal Entity
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Résumé du poste
Johnson & Johnson’s Orthopaedics team is seeking a Senior R&D V&V Engineer to verify and validate robotic medical devices, ensuring compliance with FDA, ISO 13485, and IEC standards. The role involves cross‑functional collaboration across systems, software, hardware, and manufacturing to deliver robust V&V plans and documentation.
The position requires strong engineering depth, attention to regulatory detail, and the ability to operate in a regulated environment.
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.
Responsabilités
- Collaborate with systems engineering to ensure requirements clarity, testability, and traceability.
- 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.
- Prepare and deliver system‑level V&V documentation and reports.
- Oversee maintenance of robotics test lab facilities and ensure compliance with safety standards.
- Support regulatory submissions and product launches; drive root cause analysis and corrective actions.
Connaissances
Formation
Description du poste
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.
Job Function: R&D Product Development
Job Sub Function: Robotics
Job Category: Scientific/Technology
All Job Posting Locations: Gières, Isere, France
About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Senior R&D V&V Engineer.
The Senior Robotics Verification & Validation (V&V) Engineer is responsible for ensuring that robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements. The Sr. Robotics V&V Engineer works cross functionally with systems, software, hardware, robotics, manufacturing, and quality teams to ensure design outputs are thoroughly verified and validated against user needs, intended use, system and subsystem requirements, and risk controls. This role requires strong technical depth, excellent collaboration skills, and the ability to operate effectively in a regulated, multidisciplinary environment. You will be responsible for: In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Collaborate with systems engineering to ensure requirements clarity, testability, and traceability from user needs, system and sub-system requirements, 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. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if 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 Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams. Support project resource and schedule planning.
- 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.
- Proficient in sample size calculation and statistical methods for analyzing data.
In office expectations are a minimum of 3 days per week, up to 5 days per week depending on project demand. An estimate of travel up to 30% may be required both domestic and international.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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.
- Analytical Reasoning
- Computer Programming
- Data Science
- Industry Analysis
- Innovation
- Manufacturing Technologies
- Prototyping
- Research and Development
- Robotic Automation
- Robotic Control Software
- Root Cause Analysis (RCA)
- Safety-Oriented
- SAP Product Lifecycle Management
- Smart Systems
- Technical Credibility
- Technologically Savvy
- Testing
- Analytical Reasoning
- Computer Programming
- Data Science
- Industry Analysis
- Innovation
- Manufacturing Technologies
- Prototyping
- Research and Development
- Robotic Automation
- Robotic Control Software
- Root Cause Analysis (RCA)
- Safety-Oriented
- SAP Product Lifecycle Management
- Smart Systems
- Technical Credibility
- Technologically Savvy
- Testing
The anticipated base pay range for this position is: €44.100,00 - €71.070,00
- In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
- Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well‑being reimbursement, programs for financial, physical and mental health.
- We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
- For more information, visit Employee benefits | Supporting well‑being career growth | Johnson Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
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/.
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