Software Engineering Manager in Pleasanton, CA at Johnson Service Group

Date Posted: 2/9/2021

Job Snapshot

Job Description

JobID: 382406

The Software Engineering Manager will own the full stack for connected medical devices, personally develop applications and supervise talent responsible for embedded systems design, software testing, back-end development, DevOps. This expert will immediately start development of future products and will sustain software and contractors for the currently marketed product line, working closely with systems engineering, operations, quality and commercial teams.

New software development activities will evolve, initially from medical device embedded system and application design, development and validation. 


Duties and Responsibilities

  • Ensures adherence of SDLC to FDA guidelines and ISO 62304
  • Ensure software development complies with per Software Development Life Cycle (SDLC)
  • Ensure architecture and design appropriate for budget, regulatory and user needs
  • Medical device software documentation creation, maintenance
  • Creates and executes software release plans to achieve product roadmap
  • Work closely with other engineers, technicians, contractors or other support personnel to design, debug, achieve and optimize product performance
  • Participate in product development teams as the primary software full stack engineer
  • Adheres to medical device Design Controls process throughout design, development and testing and transfer.
  • Ensure interface specifications are included in completed deliverables
  • Leads software design reviews and participates in system design reviews, providing or garnering input to design
  • Critical assessment of software and firmware architectures, state machines and coding
  • Perform and garner medical and cybersecurity risk assessments and develop design mitigation solutions to achieve required risk level through all phases of development
  • Perform routine analysis of test results in relation to design specifications and test objectives
  • Define test cases, guide test protocol creation & execution and prepare & publish verification reports
  • Coordinate activities with outside suppliers and consultants to ensure timely completion of deliverables.
  • Architect data flows to support first-party and third-party medical record systems
  • Oversee design of BTLE and USB API’s for data transfer and device control
  • Maintain server architecture
  • Develop and/or enhance software application components
  • Proficiency with ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 62304.
  • Software requirements generation
  • Software Development Lifecycle principles and practice
  • Design Controls principles and practice
  • Full stack development
  • Application development (Android, iOS)
  • Languages: Java or Kotlin, Swift, at least one server-side language and framework, some experience with C or C++
  • Understanding of cloud-based infrastructure as a service
  • Structured software testing
  • Knowledge of cybersecurity and privacy principles

#D800




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