Bracco · 7 hours ago
Senior Software Engineer (Sustaining) Bracco Medical Technologies
USA - Eden Prairie
Full-time
Onsite
Senior Level
$133K/yr - $146K/yr
5+ years expBracco Medical Technologies is committed to fostering a supportive work environment for its employees while ensuring the reliability and compliance of its medical devices. The Senior Software Engineer - Sustaining will lead software engineering activities for commercialized medical devices, focusing on issue investigation, software updates, and regulatory compliance.
Medical DeviceHealthcareHealth CareHealth DiagnosticsMedical
Responsibilities
Serve as the technical lead for all sustaining software activities on commercialized medical devices
Lead defect investigation, root cause analysis, corrective actions, software fixes, and regression testing
Diagnose and troubleshoot field‑reported issues, CAPAs, and complaints, ensuring timely and compliant software resolution
Implement software modifications to improve reliability, address obsolescence, enhance cybersecurity posture, and maintain system compatibility
Own Sustaining Change Assessments (CA) and change control documentation for software updates
Serve as the project/technical lead for sustaining software initiatives, driving execution from project definition through release
Develop and manage project plans, schedules, deliverables, risks, and cross‑functional alignment for software sustaining efforts
Coordinate with Systems, Test, Electrical, Quality, Regulatory, Manufacturing, Service, Cybersecurity, and external partners to ensure timely and compliant project completion
Facilitate and lead project meetings, status reviews, risk evaluations, and design reviews to maintain progress and alignment
Act as a core team member for sustaining projects requiring software changes, documentation updates, and verification/validation activities
Plan, coordinate, and lead software verification, integration, and regression testing in collaboration with Systems and Test Engineering
Oversee software build creation, version control, configuration management, and release readiness
Manage software deployment into manufacturing and field environments, ensuring documentation and release artifacts meet QMS and regulatory requirements
Create, maintain, and update software design documents, change records, verification protocols, DHF traceability, and audit‑ready documentation
Ensure sustaining engineering work products meet regulatory and quality expectations (FDA, ISO/EN, UL, CE, cybersecurity guidance, PDP, QMS)
Support inspections, audits, and regulatory submissions by providing complete, accurate, and compliant records
Mentor junior engineers and provide technical and project leadership within the software sustaining domain
Drive improvements to sustaining processes, tooling, documentation quality, and cross‑functional execution effectiveness
Qualification
Required
Bachelor of Science in Computer Engineering, Computer Science, Software Engineering, or related discipline
Minimum of 5 years of professional experience developing and maintaining software in regulated industries (Medical, Automotive, Aerospace, etc.)
Extensive experience with software sustaining activities for released products
General working knowledge in C, C++, C#, and/or similar programming languages
Experience with Windows-based application development or Linux
Strong leadership, organizational, and mentoring skills
Demonstrated commitment to continuous improvement and quality excellence
Demonstrated expertise in Agile development and change control processes
Strong understanding of medical device regulatory frameworks, QMS, PDP, and design control
Experience with cybersecurity practices, vulnerability assessments, and patch management
Exceptional technical writing, documentation, and verbal communication skills
Proven ability to independently lead complex technical initiatives and influence cross-functional teams
Preferred
Experience with legacy system modernization and sustaining strategies
Knowledge of Windows Presentation Foundation (WPF)
Familiarity with clinical radiology and contrast injector systems
Experience working with FDA, UL, CE, and ISO/EN compliance requirements
Understanding of embedded systems and system-level software interactions
Benefits
Paid Time Off, Company Holidays & Paid Family Leave
Achieve
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Company
Bracco
Bracco specializes in diagnostic imaging for the healthcare sector.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Diana Bracco
Founder, CEO & President
Stuart Mickelberg
Chief Compliance Officer & Legal Counsel, North America
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