Principal Verification

Principal Verification & Validation EngineerJoin to apply for the Principal Verification & Validation Engineer role at Recor MedicalPrincipal Verification & Validation Engineer1 day ago Be among the first 25 applicantsJoin to apply for the Principal Verification & Validation Engineer role at Recor MedicalAt Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.Position SummaryThe Principal Verification & Validation Engineer leads the planning, execution, and documentation of verification and validation activities for medical device products. This role ensures product quality and regulatory compliance through comprehensive testing programs, while driving innovation in V&V methodologies and maintaining alignment with design controls and risk management requirements.Responsibilities And DutiesLead development and execution of verification and validation strategiesDesign and implement test protocols for product and process validationDevelop validation master plans aligned with regulatory requirementsOversee design verification testing programs and documentationLead process validation activities including IQ/OQ/PQ protocolsEstablish test methods and acceptance criteria for product testingManage validation of manufacturing processes and equipmentDirect software verification and validation activitiesAnalyze and interpret test data using statistical methodsAuthor comprehensive V&V documentation and technical reportsReview and approve validation protocols and reportsEnsure compliance with FDA, ISO 13485, and other regulationsSupport regulatory submissions with V&V documentationCollaborate with R&D, Manufacturing, and Quality teamsManage external testing laboratories and validation contractorsPerform risk assessments and support risk management activitiesLead investigation of test failures and implement correctionsSupport design reviews with V&V expertise and insightsMaintain validation status of products and processesDrive continuous improvement in V&V practicesDevelop and maintain V&V procedures and work instructionsSupport quality system audits and inspectionsRequirementsB.S./MS in Engineering (Biomedical, Mechanical, or Electrical preferred)10+ years of V&V experience in medical device industryExpert knowledge of design controls and validation requirementsStrong background in statistical analysis and DOEExperience with risk management per ISO 14971Proven track record of successful validation projectsIn-depth knowledge of FDA and ISO requirementsExperience with software validation (IEC 62304)Strong project management and leadership skillsExcellence in technical writing and documentationExperience with validation of automated systemsKnowledge of sterilization validation requirementsProficiency in test method development and validationStrong problem-solving and analytical abilitiesPreferred QualificationsPhD in Engineering or related fieldASQ CQE or similar certificationExperience with human factors validationBackground in product developmentSix Sigma certificationKnowledge of process analytical technology (PAT)Technical SkillsStatistical analysis softwareTest automation systemsQuality management systemsData acquisition systemsProject management toolsRisk analysis toolsMicrosoft Office SuiteValidation management softwareSalary Range: $180,430 - $218,313 (Annual Base Salary)The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.Equal Employment OpportunityAt Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company’s privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant’s application for employment, a Contract Worker’s work, or a Former Employee’s employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at Recor Medical by 2xGet notified about new Verification Validation Engineer jobs in Palo Alto, CA.Cupertino, CA $165,500.00-$293,800.00 16 hours agoManufacture and Test Engineer, Rack IntegrationCupertino, CA $165,500.00-$248,700.00 4 hours agoSunnyvale, CA $68,077.00-$125,923.00 2 weeks agoSystems Verification & Validation Engineer/Scientist (Must Have Flow Cytomtery)San Jose, CA $133,300.00-$186,800.00 1 week agoWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr