Safety Management Systems Specialist

GoogleMountain View, CaliforniaFull TimeOn Site


Minimum qualifications:

  • Bachelor’s degree in Engineering or equivalent practical experience.
  • 5 years of experience in design quality engineering and safety risk management in the medical device industry, with focus on software as a medical device.
  • Experience applying medical device requirements to software as a medical device and Artificial Intelligence.
  • Experience in supporting regulatory audits.

Preferred qualifications:

  • Master’s degree in Engineering or a related field.
  • Certification in Quality Engineering.
  • Experience in managing safety risk assessments for cloud based Software as Medical Devices (SaMD).
  • Experience working with novel technologies in an ambiguous and innovative environment.
  • Experience with global safety standards and regulations (e.g., FDA Quality System Regulation, ISO 13485, ISO 14971, DCB 0129, IEC 62304, AAMI TIR 45 and IEC 6236).
  • Excellent organizational and written/verbal communication skills.

 

About the job

The Google Compliance team makes sure that our business is always consistent with the current financial regulations. Comprised of multitaskers, this team balances Google's legal and compliance requirements with the dynamic needs of our users and the values of our company. As part of this team, you proactively identify pain points and gaps in existing policy frameworks and find innovative solutions. You develop efficient compliance systems and work with teams to implement these across the organization. You are thorough in all you do and see to it that as Google pursues our next big idea, we always have our bases covered.

As a Safety management specialist, you will be responsible for implementing robust and efficient design control and risk management processes, and maintaining optimal quality and safety throughout the product life-cycle.

In this role, you will work closely with Product and Design as part of the Digital Health Regulatory, Quality and Safety team to build high quality applications that create intuitive and safe software app experiences with real impact in today's healthcare.

Google Health is a company-wide effort to help billions of people be healthier. We work toward this vision by meeting people in their everyday moments and empowering them to stay healthy and partnering with care teams to provide more accurate, accessible, and equitable care. Our teams are applying our expertise and technology to improve health outcomes globally – with high-quality information and tools to help people manage their health and wellbeing, solutions to transform care delivery, research to catalyze the use of artificial intelligence for the screening and diagnosis of disease, and data and insights to the public health community.

The US base salary range for this full-time position is $122,000-$183,000 + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits. Learn more about benefits at Google.

 

Responsibilities

  • Collaborate with Product, Engineering, Clinical, Business Development, Legal and other key functions to develop a safety and quality plan for product development and a methodical approach to safety risk management.
  • Help teams at Google to understand and meet applicable regulatory requirements for quality and safety risk management, including FDA QSR, ISO 13485, ISO 14971, DCB 0129 and other relevant procedures.
  • Provide Safety Risk Management expertise and guidance to the product teams ensuring consistent application of all Safety Risk Management standards.
  • Author and facilitate detailed safety risk assessments, product plans and reports for design quality and safety risk management, including post-market monitoring and closed loop corrective action.
  • Help develop, adapt and scale the processes for design quality and safety risk management that are required by regulations and considered as good SDL practices in a technology company.

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