Senior Software Quality Engineer

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 Senior 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 Senior 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.

• Utilize knowledge of risk management to ensure a risk-based approach for QMS processes.

• Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system using: quality policy, quality objectives, audit results, analysis of data, etc.

• Support internal audits and external audits by regulatory agencies, as required.

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.

• 3 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

• Wo