About the position
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. 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.
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.
Requirements
- 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.
- Working knowledge of IEC 62304, FDA's General Principles of Software validation, ISO 13485, ISO 14971, 21 CFR 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.
Nice-to-haves
- Masters or Advanced Degree
- ASQ certification as a Software Quality Engineer
Benefits
- Medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- 401(k) retirement plan.
- Annual performance bonus.
- Vacation - up to 120 hours per calendar year.
- Sick time - up to 40 hours per calendar year.
- Holiday pay, including Floating Holidays - up to 13 days per calendar year.
- Work, Personal and Family Time - up to 40 hours per calendar year.
