About The Position

The role will be responsible for the full SW architecture of cloud connectivity, focused around device data management and over the air updates. Leading a small group of software engineers to bring cloud connectivity and security to new medical devices. Working with the support of a larger organization, but with cutting edge devices, this role requires leadership. communication, system/software architecture, and process development.

Requirements

  • Bachelor’s Degree in Computer Science or similar.
  • Minimum of 10 years (prefer 15+ years) working as a Software Engineer with 3+ years in a software architect or principal engineer role.
  • Proven design experience designing software for complex Class II or Class III medical systems.
  • Experience working within a regulated industry, operating within a medical quality system, and a solid understanding of IEC 62304, ISO 14971, ISO 13485, and FDA QSRs.
  • Experience defining a security architecture.
  • Familiarity with safety classification of software items and software risk management.
  • Experience with version control (e.g., Git), requirement management (e.g., DOORS, Jama), and issue tracking tools (e.g., Jira).
  • Strong written and verbal communication skills.
  • Willingness to work on a small team in a fast-paced environment.

Responsibilities

  • Defining SW design inputs and design
  • Lead development of cloud based features for a suite of medical devices
  • Collaborate with company cloud infrastructure, regulatory, quality, and deployment strategists
  • Ensure compliance with IEC 62304, FDA regulations, and various regulations required in a global deployment
  • Contribute to system risk analyses to ensure compliance with guidelines such as ISO 14971
  • Mentor and develop cloud and security skillset within the team

Benefits

  • medical insurance
  • dental insurance
  • vision insurance
  • 401(k) retirement plan
  • life insurance
  • long-term and short-term disability insurance
  • paid parking/public transportation
  • paid time off
  • paid sick and safe time

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What This Job Offers

Job Type

Full-time

Career Level

Mid Level

Number of Employees

5,001-10,000 employees

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