Senior Software Validation Engineer – Medical Devices

United Pharma; Indiana; On-site; USD 110,000 - 170,000; Full time

Job summary

United Pharma is seeking a Senior Software Validation Quality Engineer to lead validation of internally developed software used in design of patient-matched orthopedic implants. The role demands hands-on execution and scalable processes for future updates.

The ideal candidate has 5+ years in software validation or quality within a regulated medical device environment, with 8+ years preferred, and can work independently to establish SOPs, documentation, and traceability.

Qualifications

• 5+ years experience in software validation or software quality.
• Experience in a regulated medical device environment preferred.
• Strong understanding of formal software validation processes and documentation.

Responsibilities

• Lead and support validation of internally developed software used in the design and development of patient-matched orthopedic implants.
• Develop and execute validation strategies, protocols, test plans, and documentation.
• Define validation requirements based on intended use, functionality and risk.
• Collaborate with Software Engineering, Quality, Regulatory and cross-functional teams to ensure compliance.
• Establish SOPs and processes for software validation.
• Develop a scalable validation framework for future updates and releases.
• Evaluate requirements, risk assessments, test results, deviations, and validation evidence.
• Ensure documentation and traceability throughout the lifecycle.
• Support cybersecurity, access controls, data integrity, and HIPAA/privacy considerations.
• Identify gaps and drive improvements in validation processes.
• Guide internal teams on software quality and validation expectations.

Skills

Software validation

Quality assurance

Regulatory compliance

Independent work

Documentation

Education

Bachelor's degree in Engineering/CS/Software or related

Job description

United Pharma is seeking a Senior Software Validation Quality Engineer to lead validation of internally developed software used in design of patient-matched orthopedic implants. The role demands hands-on execution and scalable processes for future updates.

The ideal candidate has 5+ years in software validation or quality within a regulated medical device environment, with 8+ years preferred, and can work independently to establish SOPs, documentation, and traceability.