Systems Software Engineer with Healthcare regulatory compliance (IEC 62304, FDA, DHF)Needed - Onsite - Max Rate: $50 on C2C
Rajesh Chintala
Hi,
This is Rajesh from GAC Solutions; I have an excellent job opportunity with one of our premier clients. Since it is an urgent requirement your prompt response is appreciated.
The following is a brief job description for your reference.
Job Title: Systems Software Engineer
Location: Waukesha, WI (On-Site)
Client: Capgemini
Job ID: CGEMJP00323098
JOB
DESCRIPTION:
We are seeking a highly motivated and skilled Systems Software Engineer to lead
the design, development, integration, and maintenance of foundational software
systems for medical imaging and diagnostic platforms. This role requires a
strong systems engineering mindset, with a focus on translating complex
requirements into scalable, reliable, and compliant software solutions across
both cloud-native and on-premises environments.
You will collaborate across organizational boundaries and cross-functional
teams to drive requirements flow-down, risk assessments, and verification and
validation activities. Your work will ensure robust system integration,
performance optimization, and reliability, all in alignment with regulatory
standards. The ideal candidate brings deep technical expertise in embedded
systems, cloud technologies, and regulated healthcare software development,
along with strong problem-solving and communication skills to support product
development from concept through clinical evaluation and field deployment.
Key Responsibilities:
- Conduct software component and product integration to maximize performance and operability.
- Lead design reviews, technical risk assessments, trade-off analyses, and FMEA assessments for new features and system enhancements.
- Design and implement system-level software components for both cloud-native and on-premises applications for medical imaging platforms.
- Manages software and systems requirements, specifications and flow down. Drives verification and validation activities for the overall product/system/SW application, including system level testing.
- Responsible for performing gap assessments and driving CTQ / risk decisions within the team to ensure compliance with regulatory standards (e.g. IEC 60601, FDA) and cybersecurity protocols.
- Ensure software reliability, scalability, and maintainability through rigorous testing and documentation.
- Develop and execute system verification and validation test procedures.
- Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters.
- In-depth understanding of how their work integrates with other teams and contributes to business objectives.
- Strong interpersonal skills to lead other engineers and explain technical concepts to non-technical stakeholders.
What are the Mandatory skills and skill proficiencies required for this position?
- Bachelor’s or master’s degree in computer science, Electrical Engineering, or related field.
- 5+ years of experience in system software development, with at least 2 years in cloud (AWS or other cloud platforms) application development.
- Proficiency in C/C++ and Python; experience with Linux kernel and embedded systems.
- Experience with containerization (Docker), orchestration (Kubernetes), and CI/CD pipelines (GitLab, Artifactory).
- Solid understanding of distributed systems, SOA, and n-tier architecture.
- Familiarity with Agile tools (e.g., Rally, Confluence) and software lifecycle management.
- Experience with healthcare quality and regulatory compliance (e.g., DHF, V&V, IEC 62304).
- Strong analytical and problem-solving skills; ability to work independently and in teams.
- Self-starter with a results-oriented mindset and ability to manage multiple priorities.
What are the Optional skills and skill proficiencies for this position?
- Familiarity with the GE HealthCare Quality Manual, Quality Management System, and Quality Goals.
- Knowledge of cybersecurity frameworks and secure software development practices.
- Experience with Infrastructure as Code (e.g. Terraform, CloudFormation).
- Strong communication skills across time zones and distributed teams.
- Ability to adapt and collaborate with diverse teams.
- Understanding of organizational vision and ability to align personal and team goals.
Thanks,
Chintala Rajesh
Technical Recruiter
‘Experts in Digitalization and Engineering - Enterprise 4.0’