Job Summary
Mechanical Product Validation Engineer with 5-10 years of experience in the medical device industry specializing in cleaning sterilization and reprocessing validation of reusable medical devices. Skilled in feasibility studies validation protocols test method development GR&R risk management (DFMEA/PFMEA) statistical analysis and root cause investigations. Experienced in cross-functional collaboration to support compliant product development and successful product launches.
Responsibilities
Required Qualifications
B.E./B.Tech in Mechanical Engineering or equivalent with 5-10 years of experience in the medical device industry.
Hands-on expertise in cleaning sterilization and reprocessing validation for reusable medical devices.
Proven experience in developing and validating cleaning and sterilization test methods including feasibility studies and validation protocols.
Strong knowledge of validation methodologies including GR&R studies root cause analysis and statistical data evaluation.
Experience supporting risk management activities design reviews and cross-functional project teams throughout the product development lifecycle.
Familiarity with applicable regulatory and industry standards for reusable medical devices including validation and documentation requirements.
Strong technical writing problem-solving and communication skills with the ability to collaborate effectively across engineering quality and regulatory functions.
Develop soiling cleaning and extraction processes for reusable scopes and instruments and accessories (I&A) incorporating real world use conditions and cleanability considerations.
Plan execute and analyze Cleaning and Sterilization (C&S) feasibility studies cleanability assessments and sterilization validations for reusable scopes and I&A.
Create and qualify test methods perform Gage Repeatability & Reproducibility (GR&R) studies and document results in engineering studies test protocols reports and validation documentation including statistical analysis as required.
Conduct root cause analysis for C&S process issues and evaluation findings and communicate data driven solutions and recommendations to R&D and cross functional stakeholders.
Support development and completion of associated risk management documentation (e.g. DFMEA PFMEA hazard analyses) by providing hands on laboratory expertise and technical input.
Support Design Reviews and Phase Exit Reviews by preparing required documentation developing presentation materials and presenting technical content related to cleaning sterilization and reprocessing.
Partner with internal teams and external supplier resources (e.g. test laboratories sterilization vendors) to ensure timely completion of product development and launch deliverables.
Things to know before you apply
- Work authorization: Cognizant will only consider applicants for this position who are legally authorized to work in Canada without requiring employer sponsorship, now or at any time in the future.
- Accommodations: If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email [email protected] with your request and contact information.
- AI in hiring: We use artificial intelligence (AI) tools to help us screen and assess applications more efficiently. Our team performs additional human review and ultimately decides who moves forward in our hiring process.
- Open position: Unless otherwise stated, this job posting is for an open position on our team.
- Language proficiency: We ask that all candidates have basic English proficiency for company-wide communications purposes. For roles based in Quebec, professional English proficiency is required, as you’ll deliver services to and collaborate with stakeholders outside the province who may not speak French.
- Inclusion: Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, provincial or local laws.
About Cognizant
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, bridging the gap between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, drive tangible outcomes and keep global enterprises ahead in a fast-changing world. See how at cognizant.ai or @cognizant.
