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Form of workAuris Health, a member of Johnson and Johnson Family of Companies, is recruiting a Senior Software Quality Engineer to be located in Santa Clara, CA.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
The Senior Software Quality Engineer is responsible for supporting product quality and reliability ensuring the implementation of ground breaking technology for medical devices is safe, effective, and follows applicable regulations, standards, and industry practices. Work closely with multi-functional teams, this individual will act as a domain authority for product quality throughout the development lifecycle. Also, reviews and assesses development activities (e.g., user needs, development / quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities:
- Review all project/program software development artifacts (e.g., plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
- Provides direction and leadership for verification & validation of non-product software, products software, software tools and components.
- Guide in establishing good software requirements, specifications, detailed design, verification & validation protocols and planning documentation.
- Collaborate with project/program teams to ensure software deliverables and tasks align with company procedures, global standards (ISO 13485, ISO14971, IEC62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Regulation (MDR)), and applicable guidance.
- Participate in technical design reviews and project phase reviews.
- Apply knowledge of risk management to ensure a risk-based approach for design and development.
- Identifies and implements any changes vital 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 and external audits by regulatory agencies, as required.
- Responsible for communicating business related issues or opportunities to next management level.
- A minimum of a Bachelor's Degree is required. Focus degree in Engineering, Computer Science or STEM (Science, Technology, Engineering, Math) is preferred.
Required:
- A minimum of 6 years of work experience with quality assurance with a focus on software testing, design controls, software development, and or software verification & validation
- Experience in medical device industry or other highly regulated field (Aerospace, Aviation, Automotive and/or Defense)
- Knowledge and proven application of standards such as IEC62304, FDA's General Principles of Software Validation, ISO 14971, and IEC60601-1
- New product development experience
- Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms
- Experience with FPGA logic (VHDL, Verilog) and architectures
- Prior experience working on consumer electronic equipment
- Strong verbal and written communication skills; ability to present issues, plans and objectives is required
- Previous work experience engaging in a team-based environment is required
- ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and a Green Belt in one or more of the Process Excellence roadmaps (DMADVV, DMAIIC, or Lean)is preferred
- This position may require up to 10% of domestic or international travel
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 and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
