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
At Cognizant, we strive to provide flexibility wherever possible, and we are here to support a healthy work-life balance through our various wellbeing programs. Based on this role’s business requirements, this is an onsite position requiring work at a client or Cognizant office in Highland Heights, Kentucky.
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:
Applications will be accepted until May 30th, 2026
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.
A comunidade Cognizant:
Somos uma equipe de alto calibre que aprecia e apoia uns aos outros. Nosso pessoal defende um local de trabalho enérgico, colaborativo e inclusivo, onde todos possam prosperar.
- A Cognizant é uma comunidade global com mais de 300,000 funcionários em todo o mundo.
- Não sonhamos apenas com um caminho melhor – nós fazemos acontecer.
- Cuidamos de nossas pessoas, clientes, empresa, comunidades e clima fazendo o que é certo.
- Promovemos um ambiente inovador onde você pode construir o plano de carreira certo para você.
Quem somos:
Cognizant (NASDAQ: CTSH) é uma construtora de IA e fornecedora de serviços de tecnologia, criando a ponte entre o investimento em IA e o valor para as empresas por meio do desenvolvimento de soluções de IA completas para nossos clientes. Nossa profunda experiência em setores, processos e engenharia nos permite incorporar o contexto único de cada organização em sistemas tecnológicos que potencializam a capacidade humana, geram retornos concretos e mantêm empresas globais à frente em um mundo em rápida transformação. Saiba mais em www.cognizant.com ou @cognizant.
A Cognizant é uma empregadora que investe em equidade. Sua candidatura não será pautada em raça, cor, gênero, sexualidade, credo, origem, deficiência, gravidez ou qualquer outra característica protegida pelas leis brasileiras.
Disclaimer:
As informações de compensação são precisas a partir da data desta publicação. A Cognizant se reserva o direito de modificar essas informações a qualquer momento, sujeito à lei aplicável.
Os candidatos podem ser obrigados a comparecer a entrevistas presenciais ou por videoconferência. Além disso, os candidatos podem ser obrigados a apresentar seu documento de identificação emitido pelo estado ou governo atual durante cada entrevista.
Embora nosso sistema permita a candidatura em todos os idiomas, o(s) idioma(s) e o(s) nível(is) de proficiência exigidos para o trabalho variam. No entanto, é necessário um nível básico de inglês para fins de comunicação em toda a empresa.
Se você tem uma deficiência que requer adaptações razoáveis para procurar uma vaga de emprego ou enviar uma candidatura, envie um e-mail para [email protected] com sua solicitação e informações de contato.