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Software Quality Engineering Lead, Surgical Robotics

Company: Auris Health
Location: Redwood City
Posted on: January 16, 2022

Job Description:

Ethicon, part of Johnson & Johnson Medical Devices Companies, is recruiting for a Software Quality Engineering Lead, located in Redwood City, CA. -Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery. This includes the MONARCH - platform, a first-of-its-kind robotic technology indicated for bronchoscopic -visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit -.As a Software Quality Engineering Lead, this individual 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. This individual is seen as both a people and technical leader within the organization, interfacing with cross-functional teams to ensure effective execution to business and organizational priorities. 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.Job Responsibilities:Manages Direct Reports and oversees their medical device software projects to ensure compliance to local procedures and regulatory requirements. - 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 company procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ 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.Other duties as assigned 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.QualificationsRequired: Bachelor of Science degree in Engineering or Computer Science Minimum 8 years' experience with quality assurance with a focus on software testing, design control of software development, software verification and validation Minimum 6 years' experience in a quality role within the medical device, aerospace/defense or other highly 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 MDD/MDR Ability to manage priorities and workflow Versatility, flexibility, and a willingness to work within constantly changing prioritiesTravel 25%Ability to work at the Redwood City, CA site Preferred: Advanced Degree - 2 years' experience in direct management and career development for employees - Primary LocationUnited States-California-Redwood City-150 Shoreline DrOrganizationAuris Health, Inc. (6267)Job FunctionEngineeringRequisition ID2105953145W

Keywords: Auris Health, Redwood City , Software Quality Engineering Lead, Surgical Robotics, IT / Software / Systems , Redwood City, California

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