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:

Santa Clara, California, 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

Johnson & Johnson is recruiting for a Staff Software Quality Engineer, located in Santa Clara, CA.

Our team advances the MONARCH™ surgical robotics platform by providing quality engineering support and leadership for design of new products and design changes for commercial products. We collaborate on breakthrough medical technologies that unite multiple subject areas to improve patient outcomes and advance medical professionals’ skills.

The Staff Software Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices. Working closely with multi-functional teams this individual will act as an authority for both product and non-product software quality throughout the development lifecycle. The individual reviews and assesses software activities (e.g. user needs, software development plans, software requirements, software architecture and design, product security, software verification and validation) to ensure that they comply with applicable procedures standards and regulatory requirements. Additional responsibilities may include but are not limited to supporting other areas of the Quality Management System such as CAPA, Complaints, software problem resolution and both Internal and External Audits.

Key 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.
• 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.
• Support internal audits and external audits by regulatory agencies, as required.
• Provide expertise in non-product software validation for software tools used in product manufacturing, testing and the quality system.
• Provide training and mentorship to the quality engineering team and broader organization on quality standards and best practices

Qualifications

Required:

• Bachelor of Science degree in Electrical, Computer Science or any related engineering field.
• 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.
• Strong verbal and written communication skills; ability to present issues, plans and objectives.
• Excellent organizational, problem solving, and analytical skills
• 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.
• Ability to manage priorities and workflow Versatility, flexibility, and a willingness to work within constantly evolving priorities

Preferred:

• Masters or Advanced Degree
• ASQ certification as a Software Quality Engineer

Other:

• Ability to travel up to 10% domestic and international is required

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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$141, 000 to $227, 700

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits