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Hi,

Hope you're doing well.

I am reaching out to you regarding a job opportunity with one of our clients. Let me know your thoughts.

Role: Senior Software Development Engineer (Embedded Systems)

Location: [Pittsburgh, PA, 15231] (Onsite,)

Work Authorization: No OPT

CANDIDATES MUST HAVE MEDICAL DEVICE INDUSTRY EXPERIENCE. PREFERABLY FDA EXPERIENCE. 

Job Description: 

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 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 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 judgemen,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

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.

Manisha Soy

Technical Recruiter

[email protected]

Techcenter Technologies Inc

3240 East State Street Ext, Hamilton, NJ 08619