Software Development Manager in Pleasanton, CA at Johnson Service Group

Date Posted: 5/4/2022

Job Snapshot

Job Description

JobID: 388248

Johnson Service Group is looking for a 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.

New software development activities will evolve, initially from medical device embedded system and application design, development and validation, then to Electronic Health Record (EHR) system integration via application development and web site creation for hardware support.

This key team member will be responsible for creating and maintaining software documentation (procedures, protocols, reports, analyses) related to regulatory filings, as they relate to medical device software.

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
  • Competencies
  • Software talent sourcing, recruiting and talent development
  • 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)
  • Project Management
  • Agile Development
  • Operating Systems: Android, iOS, Windows
  • Understanding embedded systems
  • Languages: Java or Kotlin, Swift, at least one server-side language and framework, some
  • experience with C or C++
  • DevOps
  • Understanding of cloud-based infrastructure as a service
  • Structured software testing
  • Knowledge of cybersecurity and privacy principles
  • Creative Problem Solving
  • Excellent written communication Supervisory Responsibility
  • Supervises and develops embedded systems development, software test and contract development personnel.
  • Work Environment
  • This job operates in a professional office as well as medical device production and development environments. This role, as well as all roles, are expected to use standard office equipment, computers, and to continually adapt to new technologies and changing work environments. The work environment is primarily located in Pleasanton, CA.

Travel

  • Up to 5% travel may be required, likely limited to domestic travel.

Required Education and Experience

  • Bachelor’s Degree in Computer Science, Electrical or Computer Engineering or equivalent with 6+ years relevant experience
  • Mobile App development for consumer devices
  • Full stack development
  • Android development
  • Mobile Apps development for Android and iOS
  • Web application and server architecture
  • Demonstrable track record of medical or consumer product delivery to market
  • Implementation of software configuration management practices and procedures
  • Understanding of the use and application of design patterns
  • Java for Android, and embedded C/C++ programming experience
  • Sophisticated problem-solving skills with a passion for technology
  • Proficiency in debugging and trouble-shooting
  • Strong leadership, verbal and written communication skills
  • Able to work on site in Pleasanton, CA
  • Preferred Education and Experience
  • Master’s Degree in Computer Science or Computer Engineering
  • Experience with application design for Electronic Health Record (EHR) system integration
  • Mobile App development for home healthcare medical devices
  • Project Management certification
#D800



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