Vacancy expired!
- Lead firmware development and PCB design projects for infectious disease diagnostic device embedded systems, working with a cross-functional team of employees and consultants.
- Contribute to the full life cycle of R&D product development initiatives including concept development, design, testing, and transfer to manufacturing.
- Design electronic circuits, select components and perform electrical simulations
- Produce and release design documentation for fabrication and assembly
- Board bring-up, debug, and test hardware from prototype to manufacturing release
- Perform electrical design validation testing and run qualification testing
- Design and develop microcontroller firmware
- Implement algorithms such as PID control and filtering
- Implement unit testing and perform code analysis to maintain code quality
- Ensure software development complies to FDA 21 CFR 820.30 (design control), IEC 62304 (software development life cycle), and ISO 14971 (risk management).
- Coordinate design transfer activities with manufacturing engineers and contract manufacturers.
- Manage inter-disciplinary projects including setting clear priorities for projects, tracking progress, and making tradeoff decisions.
- Identify, evaluate, and manage relationships with material suppliers, engineering service partners, and equipment vendors.
- Bachelor's Degree in Computer Engineering, Electrical Engineering, Computer Science, or a related field.
- 7+ years engineering experience, preferably in a medical device/biotech company.
- Experience with Altium Designer.
- Ability to read schematics and evaluate component specifications.
- Hands-on debugging skills with test equipment (oscilloscope, logic analyzer, etc).
- Strong knowledge of C programming, Python, C assembly language.
- Experience with common embedded toolchains (e.g. IAR) and version control systems (git).
- Experience in configuration management, automated testing, and software verification and validation.
- Experience with serial protocols such as SPI, I2C, UART, etc.
- Proficient with specifying software requirements and writing design documentation.
- Experience or working knowledge of applying FDA design control requirements (21 CFR 820.30), ISO 13485, ISO 14971, IEC 60601-1 & collateral standards, EMC, CE, IVD, CLIA regulations.
- Candidate must have strong project management skills and interpersonal, relationship-building skills.
- Able to work both individually and in a team environment.
- Excellent oral and written communication skills.
Vacancy expired!