Quality Engineer with Medical device

 Start date: 24-Aug-2026  

Location: Warsaw, Indiana (hybrid role – 3 days onsite)

Duration: 9-12 months, extensions highly likely

Job:   Quality (software)  for Medical Device software 

Software Quality Engineer – Medical Device Software Development

Job Summary

The Software Quality Engineer will provide quality leadership on cross-functional product development teams responsible for developing regulated medical device software systems. This individual will serve as a subject matter expert in software quality, requirements management, software risk management, verification and validation strategy, design controls, and defect management throughout the software development lifecycle.

Key Responsibilities

• Support the design, development, verification, and validation of regulated medical device software, including Software as a Medical Device (SaMD).
• Provide technical leadership and guidance on software development processes, quality systems, and best practices.
• Partner with engineering teams to refine software requirements and ensure architecture and design documentation is complete and compliant.
• Facilitate documentation and tracking of software verification activities, including code review findings and testing results.
• Review software test execution results, manage software defects, and support root cause investigations.
• Lead software risk assessment activities and develop software risk management documentation.
• Support regulatory submissions, product registrations, and compliance documentation.
• Support internal and external quality audits and regulatory inspections related to software products and quality systems.
• Manage nonconformances, CAPAs, and corrective actions associated with software development activities.
• Provide technical support for software supplier and third-party software development audits.
• Deliver training on software development processes, quality systems, and applicable regulatory requirements.
• Mentor junior engineers and provide guidance on software quality engineering best practices.
• Ensure compliance with applicable software and medical device standards, including:
• IEC 62304
• ISO 13485
• ISO 14971
• IEC 62366
• FDA Software Guidance
• FDA 21 CFR Part 11
• EU MDR
• ISO 27001
• HIPAA
• Ensure software products meet cybersecurity, privacy, electronic protected health information (ePHI), and personally identifiable information (PII) protection requirements.
• Collaborate with cross-functional teams to ensure compliance with company quality systems, policies, and applicable regulatory requirements.
• Communicate project risks, quality issues, and opportunities to leadership as appropriate.
• Follow all health, safety, environmental, and quality procedures.
• Perform additional responsibilities as assigned.

Education & Experience

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Biomedical Engineering, or a related technical discipline required.
• Minimum of four years of experience in a regulated industry within software quality, quality engineering, new product development, or manufacturing engineering.
• Experience supporting software development within a regulated medical device environment.
• Demonstrated understanding of software quality systems, design controls, software verification and validation, and risk management.
• Experience applying quality tools, processes, and methodologies to support product development.

Required Skills & Qualifications

• Strong understanding of the medical device software development lifecycle.
• Experience with Software as a Medical Device (SaMD) development preferred.
• Knowledge of software risk management, design controls, software verification and validation, defect management, and CAPA processes.
• Familiarity with FDA and international medical device regulations and standards.
• Strong analytical, organizational, and problem-solving skills.
• Excellent written and verbal communication skills.
• Ability to work effectively on cross-functional engineering teams.
• Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
• ASQ Certified Software Quality Engineer (CSQE) or equivalent certification is preferred.