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Software Development Manager-NO C2C LOCAL

Company: Johnson Service Group, Inc.
Location: Pleasanton
Posted on: January 15, 2022

Job Description:

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
Coordinate activities with outside suppliers and consultants to ensure timely completion of
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
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++
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.
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

Keywords: Johnson Service Group, Inc., Pleasanton , Software Development Manager-NO C2C LOCAL, IT / Software / Systems , Pleasanton, California

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