Lab Instrumentation - Medical Device Validation Test Lead

Jobs › Boston, MA › Lab Instrumentation

• Medical Devi… Cognizant Lab Instrumentation
• Medical Device Validation Test Lead Boston, MA Apply 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. In this role, you will:
• 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 Work model We strive to provide flexibility wherever possible.

Based on this role's business requirements, this is a remote position open to qualified applicants in United States. Regardless of your working arrangement, we are here to support a healthy work-life balance though our various wellbeing programs. 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. Rest assured; we will always be clear about role expectations. What you need to have to be considered

• 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 These will help you stand out
• Experience in regulatory affairs or compliance management operations
• Exposure to audit readiness and regulatory inspections
• Ability to create infrastructure and data flow diagrams
• Experience working in global delivery models (onshore/offshore collaboration)
• Continuous improvement mindset with the ability to drive process optimization and innovation We're excited to meet people who share our mission and can make an impact in a variety of ways.

Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.

Salary and Other Compensation:

The annual salary for this position is between $83,250 to 131,500 depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.

Benefits:

Cognizant offers the following benefits for this position, subject to applicable eligibility requirements: 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 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. Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Active Filters Lab Instrumentation

• Medical De.

.. Boston, MA Clear All Apply