Senior Software Engineer (Sustaining) Bracco Medical Technologies

Bracco • Eden Prairie, MN

8h

About The Position

This Senior Software Engineer - Sustaining leads sustaining software engineering activities for Bracco Medical Technology’s (BMT) commercialized medical devices, ensuring the ongoing reliability, compliance, cybersecurity, and maintainability of released software across both legacy and current platforms. As a senior member of the Software Engineering organization, this role provides focused technical and project leadership for sustaining efforts, driving issue investigation, software updates, documentation, and regulatory compliance. The position acts as a key bridge between Sustaining Engineering and New Product Development (NPD), minimizing disruption to innovation by owning and coordinating software sustaining initiatives from investigation through release. The role collaborates closely with cross-functional partners—including Systems, Test, Quality, Regulatory, Electrical, Manufacturing, and Service—to ensure timely, compliant, and well‑integrated software changes. Success in this role requires technical expertise, strong systems thinking, effective project leadership, and the ability to operate independently in a compliance‑driven environment. A high emphasis is placed on producing accurate, audit‑ready software documentation aligned with BMT’s Product Development Process (PDP) and Quality Management System (QMS).

Requirements

• Minimum 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.

Nice To Haves

• 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.

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.

Benefits

• Paid Time Off, Company Holidays & Paid Family Leave
• Annual incentive plan and 401k savings plan contributions
• Medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
• Tuition reimbursement program
• Hybrid or in-the-office working arrangement
• Business casual for your attire and flexibility in your schedule, wherever possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior