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Embedded Software Developer with Medical Device || Pittsburgh, PA (Onsite)
No OPT || End-client: Bayer || Woking with a Prime Vendor
Position Summary:
This position will be responsible for performing 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 Bayer product managers, and various cross-functional teams to deliver world-class solutions to Bayer 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 the position:
- Think big; bring fresh ideas and approaches to design and develop innovative solutions in medical devices to meet or exceed customer satisfaction
- Evaluate different design choices, prototype new technology, and implement technical solutions
- Understand the business impact of design choices, and make technical trade-offs using sound judgment
- Adopt engineering best practices around software development
- achieve an understanding of product requirements and software requirements to design and develop medical devices and improve customer value
- Achieve an understanding of software risk analysis and its impact on the design and implementation of medical device
- Deliver high-quality and scalable architecture designs and code
- Design and implement software for embedded devices using the 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 comply and adheres to Bayer Standard Operating Procedures that meet regulatory standards and guidance such as
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- FDA 21 CFR 820.30 – Design Controls
- FDA Cybersecurity in Medical Devices
- 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 medical device development or a regulated industry: C and C++
- Strong knowledge of MISRA C 2012 standards
- Minimum of 2 years of experience in embedded systems design with pre-emptive, multitasking in real-time operating systems (RTOS) in a medical device development or a regulated industry.
- Minimum 2 years of proven experience in communication serial protocols using SPI, I2C, and UART to communicate with peripheral sensor ICs.
- Working knowledge of tools and technologies including GitHub, Jira, Confluence, Artifactory, static analysis such as SonarQube, and CI/CD GitHub pipelines.
- Working knowledge of OS such as Windows.
- Must be able to manage multiple tasks and manage priorities accordingly.
Akash Kumar
Recruitment Team Lead
Techcenter Technologies Incorporated
3240 East State Street Ext, Hamilton, New Jersey 08619
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