Lab Instrumentation - Medical Device Validation Test Lead

About The Role

As a Lab Instrumentation - Medical Device Validation Test Lead, you will make an impact by ensuring regulatory compliance and validation of software used in medical laboratory instrumentation. You will be a valued member of the Quality Engineering and Compliance team and work collaboratively with cross-functional stakeholders across regulatory, engineering, and business teams.

Responsibilities

• Lead the development and execution of validation and test strategies for medical device and laboratory instrumentation systems
• Document and validate software in compliance with EMA guidelines and GxP regulations
• Author and maintain validation documentation, including test cases, specifications, infrastructure diagrams, and data flow diagrams
• Perform risk assessments and proactively communicate risks to stakeholders
• Provide technical leadership and mentorship to team members on validation and compliance practices
• Collaborate with cross-functional teams to ensure seamless integration of regulatory requirements
• Manage testing milestones, reporting, and ensure timely delivery of compliance outputs
• Drive continuous improvement of validation processes, frameworks, and tools

Requirements

• Proven experience in medical device or laboratory instrumentation validation within a regulated GxP environment
• Strong expertise in validation lifecycle documentation, including test cases and compliance artifacts
• Solid understanding of EMA guidelines, regulatory compliance, and IT SOPs in pharma or medical device domains
• Hands-on experience in performing risk assessments and validation activities
• Excellent technical writing and documentation skills
• Strong communication skills with the ability to collaborate across cross-functional teams
• High attention to detail with a focus on accuracy, compliance, and quality

Qualifications

• Experience in regulatory affairs or compliance management operations
• Exposure to audit readiness and regulatory inspections
• Experience working in global delivery models (onshore/offshore collaboration)
• Continuous improvement mindset with the ability to drive process optimization and innovation

Skills

• Transferable experiences and unique skills that make you stand out

Benefits

• Annual salary range: $83,250 to $131,500 depending on experience and other qualifications of the successful candidate
• Eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans
• Benefits: Medical/Dental/Vision/Life Insurance, Paid holidays plus Paid Time Off, 401(k) plan and contributions, Long-term/Short-term Disability, Paid Parental Leave, Employee Stock Purchase Plan

Pay

The annual salary for this position is between $83,250 to 131,500 depending on experience and other qualifications of the successful candidate.

Schedule

This is a remote position open to qualified applicants in the United States. The working arrangements for this role are accurate as of the date of posting. This may change based on the project you’re engaged in, as well as business and client requirements.

Disclaimer

The salary, other compensation, and benefits information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.