Senior Software Development Engineer (Embedded Systems)

Title: Senior Software Development Engineer (Embedded Systems)

Location: Pittsburgh, PA (5 Days A Week Onsite)

Duration: Long Term

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 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
• Evaluate different design choices, prototype new technology, and implement technical solutions
• Understand business impact of design choices, and make technical trade-offs using sound judgement
• Adopt engineering best practices around software development
• Achieve understanding of product requirement and software requirement to design and develop medical device and improve customer value
• Achieve understanding of software risk analysis and its impact on design and implementation of medical device
• Deliver high-quality and scalable architecture designs and code
• Design and implement software of embedded devices using SDLC process for medical device development.
• Identify opportunities to develop new and better solutions.
• Participate in code reviews of other software engineers, and design reviews
• Develop any technical documentation needed to accurately represent application design and code.
• Ensures the development initiatives of Bayer Radiology medical devices complies and adheres to Bayer 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

• Effectively collaborates within cross-functional teams across multiple geographies to convey problems, opportunities, solutions, and results in the medical device development
• Manages own work activities to given objectives

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
• Good understanding of software development processes, software architecture and data structure.
• 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.
• Working knowledge of tools and technologies including GitHub, Jira, Confluence, Artifactory, static analysis such as SonarQube, CI/CD GitHub pipelines.
• Working knowledge on OS such as Windows.
• Must be able to manage multiple tasks and manage priorities accordingly.