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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:

Employer: Auris Health, Inc.

Job Title: Primary Software Quality Engineer

• Ottava

Job Code: A011.4396

Job Location: Santa Clara, CA

Job Type: Full-Time

Rate of Pay: $110,000 - $130,000

Job Duties: Support computerized system validation activities for various platforms' Non-Product software in Surgical Robotics product development. Identify and implement necessary changes to ensure and maintain the continued suitability and effectiveness of the quality management system (QMS) using quality policy, quality objectives, audit results, and analysis of data. Apply a risk-based approach for QMS processes. Provide direction and support for verification and validation (V&V) of product software, non-product software, software tools, and components. Guide the establishment of documentation for software requirements, specifications, detailed design, V&V protocols, planning, and change control. Collaborate with project/program teams to ensure software deliverables and tasks align with applicable company procedures, global standards (ISO 13485, ISO14971, IEC62304), and regulations (21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/Medical Device Regulation (MDR)). Review all project/program software deliverables, such as plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, and reports. Review and assess development activities including user needs, development/quality plans, requirements, architecture and design, and V&V to ensure alignment with applicable procedures, standards, and regulations. Participate in technical design reviews and project phase review. As needed, support CAPA and/or internal and external audits. Communicate business related issues or opportunities to management.

Requirements: Employer will accept a Master's degree in Electrical Engineering, Computer Science or related field and 6 months of experience in the job offered or in a Primary Software Quality Engineer

• Ottava-related occupation.

This job posting is anticipated to close on 5/4/2026.

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 & 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 contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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 Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
• For additional general information on Company benefits, please go to:
• https://www.careers.jnj.com/employee-benefits

Required Skills:

Preferred Skills: