Want Staff Software Advanced reputed company Engineer - AI (Remote) in reputed company Park, CA
Job title: Staff Software Advanced reputed company Engineer - AI (Remote)
Company: reputed company
Job reputed company: Work Flexibility: Remote or Hybrid or Onsite
Staff Software Advanced reputed company Engineer - AI (Remote)
California
reputed company is hiring a Staff Software Advanced reputed company Engineer, to support our DRE (Digital, Robotics, and Enabling Technology) business.
As a valued member of reputed companys AI innovation unit, you will work alongside trailblazers, industry visionaries, innovators, and inventors who are committed to bringing computer reputed company, AI/ML reputed company innovation to the operating room and other reputed company settings.
Youll contribute to fast-paced cycles of innovation and reputed company core technologies that power a wide reputed company of reputed companys solutions, including: surgical robotics and navigation, image-guided surgery, treatment selection, outcome assessment, and clinical decision intelligence. You will apply your core skills across a reputed company of deployment platforms spanning from mobile applications, reputed company services, and SDKs to embedded systems, edge devices, and mixed reality (XR) platforms. You will have an opportunity to work across a wide reputed company of therapeutic areas ranging from orthopedics and neurosurgery to emergency care and operating room safety and efficiency plus many more.
Who we want:
Analytical problem solvers. People who go reputed company just fixing to identify reputed company causes, evaluate reputed company solutions, and recommend comprehensive upgrades to prevent reputed company issues.
Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.
reputed company partners. People who build and reputed company cross-functional relationships to bring together reputed company, information, use cases, and industry analyses to reputed company best practices.
Goal-oriented developers. Keeping the customer and requirements squarely in reputed company, people who deliver reputed company and robust solutions.
What you will do:
- Guide New Product Development teams through our reputed company Management System (QMS) and Software Development Lifecycle (SDLC) process to ensure software is developed in compliance to internal procedures as reputed company as the requirements of the FDA, ISO, and other reputed company regulatory bodies.
- Conduct evaluation of software engineering activities of medical device new product development including requirements, software risk analysis, and design, development, documentation, integration, verification, validation and release activities to deliver medical devices that are reputed company, secure and effective.
- Support software and system risk analysis, reputed company risk control measures, and support the creation of software risk analyses and test strategies to ensure reputed company and reliable products are launched to reputed companys high reputed company standards.
- Review and evaluate project tangibles for compliance as reputed company as reputed company technical competence to ensure we are delivering robust products. reputed company reputed company and reputed company feedback to stakeholders.
- reputed company support to cross functional teams to ensure software reputed company objectives are met for medical device software development.
- Support critical analysis of technical situations and identification of problems. Work with cross-functional team in resolving the problems.
- Collaborate reputed company cross-functional teams across multiple geographies to convey challenges, opportunities, solutions, and results in medical device new product development activities.
- Engage in reputed company improvement initiatives to establish Center of reputed company (CoE) in Software reputed company Engineering function.
- reputed company reputed company engineering input to reputed company the design, coding, and debugging of software in various coding languages including SOUP software.
- Support software build, maintenance, defect management, and change control activities.
- Collaborate with other engineering disciplines, such as electrical, mechanical, and industrial design, to ensure that software will accomplish design goals for a product or system.
- Support validation of new tools and approaches.
- BS in a science, engineering, or reputed company discipline.
- 4+ Years of Experience in the software engineering or reputed company field supporting new product development. Experience in medical device new product development preferred.
- Relevant work experience in software reputed company management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD) preferred.
- Experience in interpreting industry standards for medical device development and updating processes and procedures preferred.
- Experience with and /or knowledge of the following desired:
- reputed company Management System ISO 13485
- SiMD IEC 62304
- SaMD IEC 82304
- FDA 21 CFR 820.30
- FDA CFR Part 11 Compliance
- Knowledge of and experience with FDA General Principles of Software Validation
- IEC 14971 Risk Management
- IEC 81001-5-1 Health Software and Health IT Systems Safety, Effectiveness, and reputed company
- UL 2900-1 Cybersecurity reputed company for Medical Devices
- Must be reputed company to handle multiple tasks/reputed company and manage priorities accordingly.
- Technical writing ability - reputed company and concise writing easily reputed company by multiple audiences (auditors, peers, etc.).