- Location: Indiana, United States
- Type: Contract
- Job ID: 10640
- Work Setting: On-Site
- Posted: September 29, 2026
- Closing Date: April 16, 2027
- Tax Status: W2
Consultant, Senior Software Validation Quality Engineer, Medical Devices
Summary
Our client, a leading global medical device organization, is seeking a Senior Software Validation Quality Engineer to support the validation of internally developed software used in the design of patient-matched orthopedic implants.
Because the software is directly involved in the design process and generates technical information associated with the implant, it requires a more rigorous validation approach than traditional off-the-shelf software. This individual will help establish and execute a formal software validation strategy while creating a scalable process for future software updates and releases.
The ideal candidate will bring 5+ years of software validation or software quality experience, with a preference for candidates who have 8+ years of experience in a regulated medical device environment. This is an opportunity for a hands-on, experienced professional who can operate independently, drive the validation process, and help establish SOPs and documentation from the ground up.
Job Duties
Requirements
Terms & Start
Summary
Our client, a leading global medical device organization, is seeking a Senior Software Validation Quality Engineer to support the validation of internally developed software used in the design of patient-matched orthopedic implants.
Because the software is directly involved in the design process and generates technical information associated with the implant, it requires a more rigorous validation approach than traditional off-the-shelf software. This individual will help establish and execute a formal software validation strategy while creating a scalable process for future software updates and releases.
The ideal candidate will bring 5+ years of software validation or software quality experience, with a preference for candidates who have 8+ years of experience in a regulated medical device environment. This is an opportunity for a hands-on, experienced professional who can operate independently, drive the validation process, and help establish SOPs and documentation from the ground up.
Job Duties
- Lead and support the validation of internally developed software used in the design and development of patient-matched orthopedic implants.
- Develop and execute software validation strategies, protocols, test plans, and associated documentation.
- Define validation requirements based on the software’s intended use, functionality, and risk.
- Partner with Software Engineering, Quality, Regulatory, and other cross-functional teams to ensure software meets applicable quality and regulatory requirements.
- Establish and document standard operating procedures (SOPs) and processes for software validation.
- Develop a sustainable validation framework that can be applied to future software updates, enhancements, and releases.
- Evaluate software requirements, risk assessments, test results, deviations, and validation evidence.
- Ensure appropriate documentation and traceability throughout the software development and validation lifecycle.
- Support quality activities related to cybersecurity, access controls, data integrity, and HIPAA/privacy considerations.
- Identify gaps in existing software validation processes and recommend improvements.
- Provide guidance to internal teams regarding software quality and validation expectations.
- Depending on experience, potentially support aspects of software development and/or software quality engineering.
- Help ensure the software and associated technical information meet the quality expectations of a regulated medical device environment.
Requirements
- Bachelor’s degree in Engineering, Computer Science, Software Engineering, Quality, or a related technical discipline preferred.
- 5+ years of experience in software validation, software quality, software V&V, or a closely related field.
- Experience working within a regulated environment, preferably medical device.
- Strong understanding of formal software validation processes and documentation.
- Experience developing and executing validation protocols, test plans, and/or test scripts.
- Ability to independently drive a software validation process from requirements through completion.
Terms & Start
- Remote
- 6-9+ month contract, possibility of extension
- Benefits included: Medical, Dental, Vision
Pay: 60/hr