No C2C, No Sponsorship
Must reside in Pittsburgh area.
Position Title: Senior Software Development Engineer (Embedded Systems)
Position Summary:
This position will be responsible to perform software development of medical devices to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls.
Position Description:
You will be involved in all aspects of the product development lifecycle from requirements to delivery in an agile scrum framework.
You will work closely with the product managers, and various cross functional teams to deliver world-class solutions to customers.
You will design and develop high-quality medical devices exhibiting excellent performance that meets product requirements and exceeds customer satisfaction.
Major Tasks and Responsibilities of position:
· Think big; bring fresh ideas and approaches to design and develop innovative solutions in medical device to meet or exceed customer satisfaction
· Develop any technical documentation needed to accurately represent application design and code.
· Ensures the development initiatives of medical devices complies and adheres to Standard Operating Procedures that meets regulatory standards and guidance such as
o FDA 21 CFR 820.30 – Design Controls
o FDA Cybersecurity in Medical Devices
o IEC 62304 – Software in a Medical Device
Qualifications & Competencies: Bachelor’s degree in Computer Engineering, Computer Science, Electronics, or Electrical Engineering
· Minimum of 5 years of relevant work experience in software engineering including all phases of SDLC
· Minimum of 5 years of experience in programming languages and framework in a medical device development or in a regulated industry: C and C++
· Strong knowledge with MISRA C 2012 standards
· Minimum of 2 years of experience in embedded systems design with preemptive, multitasking in real-time operating systems (RTOS) in a medical device development or in a regulated industry.
· Minimum 2 years of proven experience in communication serial protocols using SPI, I2C and UART to communicate with peripheral sensor IC’s.
