JobID: 380900
Johnson Service Group has a great opportunity for a Principal Embedded Software Engineer - In Alameda County California
The successful candidate will own the design, implementation and verification of the embedded software powering the next generation of low-cost Fenom devices. These connected breath analyzers must control the pneumatic systems, implement the Nitric Oxide measurement algorithms, and transmit the results to local devices over BTLE and USB.
Manage and maintain the design of the on-market Fenom Pro product, including embedded firmware, embedded Android, and PC application.
Create detailed requirements, design and test documentation per FDA Class I & II guidelines, and ISO 62304.
Select and manage contract software testers to ensure that all releases are free from critical defects. Select and manage development partners as needed to implement mobile, desktop and web accessories.
Duties and Responsibilities
• Design and develop embedded software for prototype and commercial devices, working closely
with Design, Mechanical, Electrical and System Engineering team members
• Architect data flows to support first-party and third-party medical record systems
• Design BTLE and USB API’s for data transfer and device control
• Participate in product development teams as the primary software and embedded system design resource
• Adheres to medical device Design Controls process throughout design, development and testing and transfer.
• Generate embedded system requirements to meet device development goals
• Perform medical and cybersecurity risk assessments and develop design mitigation solutions to achieve required risk level through all phases of development
• Participate in the sensor and component selection decision making process for design changes
• Ensure interface specifications are included in completed deliverables
• Translate technical requirements into programmed application components
• Identify applicable system platform, components, and dependencies
• Documents the detailed application specifications
• Design multi-processor communication protocols, utilizing standards and best practices
• Develop and/or enhance software application components
• Develop and/or enhance embedded processor firmware applications
• Leads software design reviews and participates in system design reviews, providing or
garnering input to design
• Debug, tune and refine hardware and software iterations working concurrently with
established engineering team
• 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
• Act as a point of contact with Production on the transfer of new firmware and software
revisions to manufacturing
• Coordinate activities with outside suppliers and consultants to ensure timely delivery.
Competencies
• Creative Problem Solving
• Excellent written communication
• Firmware and real-time programming
• Sensor data acquisition and processing
• Familiarity with MATLAB
• Software requirements generation
• Structured software testing
• Knowledge of cybersecurity and privacy principles
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 continually adapting to new technologies and changing work environments. The
work environment is primarily located in Pleasanton, CA.
Travel
Up to 5% travel may be required, including domestic travel and international travel to Asia and
potentially Europe.
Required Education and Experience
• BS Computer Science, Electrical Engineering or Computer Engineering or equivalent with 5+ years relevant experience
• Training and practical experience with design controls, as they apply to device development in the medical industry
• Implementation of software configuration management practices and procedures
• Understanding of the use and application of design patterns
• Familiar with digital control and digital communication protocols, including BTLE and USB
• Experience with Object-Oriented Analysis and Design (OOA&D)
• Java for Android, and embedded C/C++ programming experience
• Experience developing Android applications
• Experience compiling and customizing the Android kernel
• Experience configuring embedded OS’s like FreeRTOS
• Experience with Atmel Studio
• Proficiency with software drivers for sensors and other hardware devices
• Proficiency with I2C, SPI, and other device interface buses
• Sophisticated problem-solving skills with a passion for technology
• Proficiency with rapid development of prototypes
• Proficiency in debugging and trouble-shooting
• Strong teamwork, verbal and written communication skills
• Self-motivated with a strong work ethic
• Able to work on site in Alameda County CA
Preferred Education and Experience
• Understanding of cloud-based infrastructure as a service
• At least six years of experience in a related regulated medical device environment
• Demonstrable track record of medical or consumer product delivery to market
• Knowledge and implementation of real time closed loop control systems
Additional Eligibility Qualifications
• Must be authorized to work in the US for any employer without sponsorship
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
