Description
Our client is an innovative medical device manufacturer in the United States that develops devices and software applications.
At this project, you will have a great opportunity to be involved into the full development life cycle of medical software, which is intended to help individuals by processing certain information taken from medical devices to identify health trends and to track daily activities. Additionally, there are opportunities to work with medical devices in the scope of end-to-end testing.
Requirements
Must Haves:
- Bachelor’s degree in Computer Science, Computer Engineering, Electrical Engineering, or a related field
- 3+ years of work experience
- Embedded / Tooling
- Understanding of QA principles and processes.
- Understanding of requirements traceability and its role in compliance and test coverage
- Proactive communicator with ability to work independently as well as collaboratively in cross functional teams.
- Clear, concise, and organized written communication skills to convey methods and observations.
- Familiarity with defect tracking tools (ideally JIRA)
- Experience in test management systems (preferably Jama Connect), including writing test cases, entering results, and facilitating review and sign off processes.
- Experience with electronic test equipment (power supplies, DMMs, oscilloscopes, etc) and ability to troubleshoot electrical and firmware issues on circuits/hardware.
- Excellent proactive communication skills, both verbal and written, including through collaboration
- tools (e.g., Jira, Confluence, Teams)
Nice to have:
- C / C++ / C# / .Net
- TCP / IP
- Some exposure to using web APIs over REST is a plus
- Familiarity with software QA processes in regulated environments (e.g., medical device, FAA, SEC, DoD, Title 21 CFR Part 11) is preferred.
- Understanding of microprocessor features such as digital I/O, timers, ADCs, UARTs, low power
modes, etc. - Comfortable reading hardware data sheets
- Experience developing drivers to control lab equipment such as oscilloscopes, multimeters, and power supplies
Job responsibilities
- Collaborate with the software team on the design, implementation, and documentation of secure software systems that support manufacturing and production processes for medical devices.
- Define and enforce cybersecurity best practices throughout the manufacturing software development lifecycle (SDLC), including code reviews, and vulnerability assessments.
- Familiarity with NIST SP 800-series security controls for software design, including the implementation of Multi-Factor Authentication (MFA), identity management, and cryptographic best practices.
- Collaborate with manufacturing engineering, IT/OT teams, quality, and regulatory functions to ensure that production software systems meet both operational and security requirements.
- Maintain secure interfaces between manufacturing equipment and other enterprise systems.
- Support compliance with medical device and cybersecurity standards, including FDA Premarket Cybersecurity Guidance, ISO/IEC 81001-5-1, IEC 62304, ISO 13485, and ISO/IEC 27001.
- Support verification and validation activities, including documentation aligned with medical device regulatory frameworks
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What we offer
Empowering Projects: With 500+ clients spanning diverse industries and domains, we provide an exciting opportunity to contribute to groundbreaking projects that leverage cutting-edge technologies. As a team, we engineer digital products that positively impact people’s lives.
Empowering Growth: We foster a culture of continuous learning and professional development. Our dedication is to provide timely and comprehensive assistance for every consultant through our dedicated Learning & Development team, ensuring their continuous growth and success.
DE&I Matters: At GlobalLogic, we deeply value and embrace diversity. We are dedicated to providing equal opportunities for all individuals, fostering an inclusive and empowering work environment.
Career Development: Our corporate culture places a strong emphasis on career development, offering abundant opportunities for growth. Regular interactions with our teams ensure their engagement, motivation, and recognition. We empower our team members to pursue their career goals with confidence and enthusiasm.
Comprehensive Benefits: In addition to equitable compensation, we provide a comprehensive benefits package that prioritizes the overall well-being of our consultants. We genuinely care about their health and strive to create a positive work environment.
Flexible Opportunities: At GlobalLogic, we prioritize work-life balance by offering flexible opportunities tailored to your lifestyle. Explore relocation and rotation options for diverse cultural and professional experiences in different countries with our company.
About GlobalLogic
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.
