Position Title: Senior Software Development Engineer (ISI)
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.
Qualifications & Competencies:
Bachelor's degree in computer engineering, 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++
- Minimum of 2 years of experience in Python framework.
- Minimum of 2 years of experience in Linux Ubuntu and SafeRTOS in a medical device development or in a regulated industry.
- Working knowledge of tools and technologies including GitHub, Jira, Confluence, Artifactory, SonarQube, CI/CD GitHub pipelines.
- Working knowledge on OS such as Windows.
- Must be able to manage multiple tasks and manage priorities accordingly.
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 develop applications and services 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.
- 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
