Sr. Engineer, Systems Software

Carex is partnering with a biotech industry partner to hire a Senior Systems Software Engineer. This onsite role in Madison, WI will work closely with the Systems Development team to design, develop, and test software used in medical devices. The position also supports the development of internal software tools and databases used across R&D, service, and quality control functions. This individual will provide technical leadership throughout the software development lifecycle while contributing to innovative, high-quality software solutions in a regulated environment.

Relocation assistance is available for qualified candidates.

• Lead and participate in all phases of the software development lifecycle.
• Translate product and quality system requirements into software specifications.
• Lead software architecture efforts for software-driven systems.
• Create and review software design control documentation with cross-functional team input.
• Document software systems and designs using accepted methodologies such as UML.
• Maintain, optimize, and improve existing software performance.
• Review, debug, and troubleshoot highly complex software and system issues.
• Develop complex software applications and associated unit tests.
• Develop and execute test strategies and test plans at both module/unit and system levels.
• Ensure software solutions meet product, regulatory, quality system, and design requirements.
• Create internal tools that improve data analysis and data management workflows.
• Collaborate with external vendors to validate software and hardware platforms.
• Provide technical leadership and mentorship to junior engineers and interns.
• Facilitate training on current software systems and development best practices.
• Partner cross-functionally with engineering and operational teams.
• Support quality management system policies, procedures, and compliance initiatives.
• Participate in occasional travel, weekend, or evening work as needed.

• Bachelor’s degree in Software Engineering or a related field.
• 6+ years of relevant industry experience in software engineering or systems software development.
• Strong understanding of software architecture, design, testing, and debugging practices.
• Experience documenting software systems using UML or similar methodologies.
• Proven ability to lead technical projects and mentor engineering team members.
• Experience developing software in regulated environments.
• Strong written and verbal communication skills.
• Ability to work onsite in Madison, WI up to 5 days per week.
• Authorization to work in the United States without sponsorship.

• 8+ years of experience working within quality systems and design controls in the medical device industry or a related regulated field.
• Experience supporting software launches from concept through customer release.
• Knowledge of medical device software lifecycle processes.
• Experience developing software for medical devices.

Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity, or Veteran status.