Johnson & Johnson is looking to advance its MONARCH™ surgical robotics platform by ensuring the quality, safety, effectiveness, and regulatory compliance of its medical devices through robust software engineering practices.
Requirements
- 6 years’ experience with quality assurance with a focus on software testing, design control of software development, software verification and validation.
- 4 years’ experience in a quality role within the medical device, aerospace/defense or similarly regulated industry.
- Working knowledge of IEC 62304, FDA’s General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR part 820, IEC 60601-1 and MDR.
- Ability to lead cross-functional teams in problem solving and risk analysis activities.
- Provide leadership and strategic direction on cybersecurity and AI/ML requirements, oversee implementation, and ensure compliance.
- Drive root cause analysis and corrective/preventive actions (CAPA) for product and process nonconformances.
- Provide expertise in non-product software validation for software tools used in product manufacturing, testing and the quality system.
Responsibilities
- Review all project / program software deliverables (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
- Provides direction and leadership for verification and validation of non-product software, products software, software tools and components.
- Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
- Collaborate with project / program teams to ensure software deliverable comply with RADS procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Medical Device Regulation (MDR), and applicable guidance.
- Provide Quality representation during software problem resolution.
- Participate in technical design reviews and project phase reviews.
- Function as the quality expert in software risk management processes throughout the entire software lifecycle.
Other
- Strong verbal and written communication skills; ability to present issues, plans and objectives.
- Excellent organizational, problem solving, and analytical skills.
- Ability to manage priorities and workflow Versatility, flexibility, and a willingness to work within constantly evolving priorities.
- Ability to travel up to 10% domestic and international is required.
- Bachelor of Science degree in Electrical, Computer Science or any related engineering field.
