Senior Robotics Verification & Validation (V&V) Engineering Manager
Johnson & Johnson, Boston, MA, United States
Job Function
R&D Product Development
Job Sub Function
R&D Software/Systems Engineering
Job Category
People Leader
Job Locations
Boston, Massachusetts, United States; Raynham, Massachusetts, United States
Job Description
About Orthopaedics: Fueled by innovation at the intersection of biology and technology, our Orthopaedics teams develop the next generation of smarter, less invasive, more personalized treatments. We aim to keep over 6 million people moving each year by delivering clinical and economic value to surgeons and healthcare systems.
Purpose
The Senior Robotics Verification & Validation (V&V) Engineering Manager leads a team that ensures robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for intended clinical use. The role supports 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 quality system requirements.
Key Responsibilities
Lead a team of Verification & Validation and Integration Engineers to meet subsystem and system level requirements.
Collaborate closely with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable.
Define minimum testable requirements following design or requirement changes, applying a risk‑based approach.
Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, overseeing investigation, integration, reliability, and formal verification and validation testing.
Prepare and deliver system‑level V&V documentation, including summary reports and verification results.
Review and approve sub‑system verification deliverables to ensure alignment with overall system requirements.
Design, validate, and implement test methods, including manual and automated test setups.
Coordinate and manage engagement with external test facilities to ensure regulatory compliance and adherence to internal policies.
Oversee maintenance of robotics test lab facilities, ensuring all equipment is calibrated, serviced, and compliant with safety, quality, and procedural standards.
Ensure compliance with regulatory standards such as 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.
Communicate business‑related issues or opportunities to senior management.
Manage health, safety, and environmental practices for the team.
Ensure personnel and company compliance with all applicable regulations, policies, and procedures.
Identify critical paths during product development, address bottlenecks and risks, and facilitate problem solving across R&D teams.
Support project resource and schedule planning.
Qualifications & Requirements
Required
Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or a related field.
7+ years of experience in V&V engineering within the medical device industry.
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).
Preferred
Experience with Class II or Class III medical devices.
Knowledge of embedded systems, firmware/software testing, or electromechanical systems.
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.
Proficiency in sample size calculation and statistical methods for analyzing data.
Pay Range
Base pay range: $137,000.00 – $235,750.00
Benefits
• Long‑term incentive program participation
• Company retirement plans (pension, 401(k))
• Vacation: 120 hours per calendar year
• Sick time: 40 hours per calendar year (48 h in Colorado, 56 h in Washington)
• Holiday pay, including floating holidays: 13 days per calendar year
• Work, Personal & Family Time: up to 40 hours per calendar year
• Parental leave: 480 hours within one year of birth/adoption/foster care
• Bereavement leave: 240 hours (40 h for immediate family, 40 h per calendar year for extended family)
• Caregiver leave: 80 hours in a 52‑week rolling period
• Volunteer leave: 32 hours per calendar year
• Military spouse time‑off: 80 hours per calendar year
Equal Opportunity & Accommodations
Johnson & Johnson is an affirmative action and 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, or protected veteran status, or disability. We will provide reasonable accommodations for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Contact us to request accommodation.
Contact & Further Information
For more information about our employment opportunities and employee benefits, visit
https://www.careers.jnj.com .
#J-18808-Ljbffr
R&D Product Development
Job Sub Function
R&D Software/Systems Engineering
Job Category
People Leader
Job Locations
Boston, Massachusetts, United States; Raynham, Massachusetts, United States
Job Description
About Orthopaedics: Fueled by innovation at the intersection of biology and technology, our Orthopaedics teams develop the next generation of smarter, less invasive, more personalized treatments. We aim to keep over 6 million people moving each year by delivering clinical and economic value to surgeons and healthcare systems.
Purpose
The Senior Robotics Verification & Validation (V&V) Engineering Manager leads a team that ensures robotic products meet all defined system and subsystem level requirements and are safe, effective, and compliant for intended clinical use. The role supports 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 quality system requirements.
Key Responsibilities
Lead a team of Verification & Validation and Integration Engineers to meet subsystem and system level requirements.
Collaborate closely with systems engineering, hardware, and software teams to ensure requirements are clearly defined, testable, and fully traceable.
Define minimum testable requirements following design or requirement changes, applying a risk‑based approach.
Develop and execute comprehensive V&V strategies and master system test plans for complex medical devices, overseeing investigation, integration, reliability, and formal verification and validation testing.
Prepare and deliver system‑level V&V documentation, including summary reports and verification results.
Review and approve sub‑system verification deliverables to ensure alignment with overall system requirements.
Design, validate, and implement test methods, including manual and automated test setups.
Coordinate and manage engagement with external test facilities to ensure regulatory compliance and adherence to internal policies.
Oversee maintenance of robotics test lab facilities, ensuring all equipment is calibrated, serviced, and compliant with safety, quality, and procedural standards.
Ensure compliance with regulatory standards such as 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.
Communicate business‑related issues or opportunities to senior management.
Manage health, safety, and environmental practices for the team.
Ensure personnel and company compliance with all applicable regulations, policies, and procedures.
Identify critical paths during product development, address bottlenecks and risks, and facilitate problem solving across R&D teams.
Support project resource and schedule planning.
Qualifications & Requirements
Required
Bachelor’s or master’s degree in biomedical engineering, Systems Engineering, Electrical Engineering, or a related field.
7+ years of experience in V&V engineering within the medical device industry.
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).
Preferred
Experience with Class II or Class III medical devices.
Knowledge of embedded systems, firmware/software testing, or electromechanical systems.
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.
Proficiency in sample size calculation and statistical methods for analyzing data.
Pay Range
Base pay range: $137,000.00 – $235,750.00
Benefits
• Long‑term incentive program participation
• Company retirement plans (pension, 401(k))
• Vacation: 120 hours per calendar year
• Sick time: 40 hours per calendar year (48 h in Colorado, 56 h in Washington)
• Holiday pay, including floating holidays: 13 days per calendar year
• Work, Personal & Family Time: up to 40 hours per calendar year
• Parental leave: 480 hours within one year of birth/adoption/foster care
• Bereavement leave: 240 hours (40 h for immediate family, 40 h per calendar year for extended family)
• Caregiver leave: 80 hours in a 52‑week rolling period
• Volunteer leave: 32 hours per calendar year
• Military spouse time‑off: 80 hours per calendar year
Equal Opportunity & Accommodations
Johnson & Johnson is an affirmative action and 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, or protected veteran status, or disability. We will provide reasonable accommodations for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Contact us to request accommodation.
Contact & Further Information
For more information about our employment opportunities and employee benefits, visit
https://www.careers.jnj.com .
#J-18808-Ljbffr