Principal Verification & Validation Engineer

Company: Otsuka Pharmaceutical Co., Ltd
Location: Palo Alto
Posted on: April 3, 2025

Job Description:

Principal Verification & Validation Engineer page is loadedPrincipal Verification & Validation EngineerApply remote type Onsite locations Palo Alto time type Full time posted on Posted Yesterday job requisition id R8940At 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 Summary :The 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 Duties:

• Lead development and execution of verification and validation strategies
• Design and implement test protocols for product and process validation
• Develop validation master plans aligned with regulatory requirements
• Oversee design verification testing programs and documentation
• Lead process validation activities including IQ/OQ/PQ protocols
• Establish test methods and acceptance criteria for product testing
• Manage validation of manufacturing processes and equipment
• Direct software verification and validation activities
• Analyze and interpret test data using statistical methods
• Author comprehensive V&V documentation and technical reports
• Review and approve validation protocols and reports
• Ensure compliance with FDA, ISO 13485, and other regulations
• Support regulatory submissions with V&V documentation
• Collaborate with R&D, Manufacturing, and Quality teams
• Manage external testing laboratories and validation contractors
• Perform risk assessments and support risk management activities
• Lead investigation of test failures and implement corrections
• Support design reviews with V&V expertise and insights
• Maintain validation status of products and processes
• Drive continuous improvement in V&V practices
• Develop and maintain V&V procedures and work instructions
• Support quality system audits and inspectionsRequirements:
• B.S./MS in Engineering (Biomedical, Mechanical, or Electrical preferred)
• 10+ years of V&V experience in medical device industry
• Expert knowledge of design controls and validation requirements
• Strong background in statistical analysis and DOE
• Experience with risk management per ISO 14971
• Proven track record of successful validation projects
• In-depth knowledge of FDA and ISO requirements
• Experience with software validation (IEC 62304)
• Strong project management and leadership skills
• Excellence in technical writing and documentation
• Experience with validation of automated systems
• Knowledge of sterilization validation requirements
• Proficiency in test method development and validation
• Strong problem-solving and analytical abilitiesPreferred Qualifications:
• PhD in Engineering or related field
• ASQ CQE or similar certification
• Experience with human factors validation
• Background in product development
• Six Sigma certification
• Knowledge of process analytical technology (PAT)Technical Skills:
• Statistical analysis software
• Test automation systems
• Quality management systems
• Data acquisition systems
• Project management tools
• Risk analysis tools
• Microsoft Office Suite
• Validation 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.
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Keywords: Otsuka Pharmaceutical Co., Ltd, Palo Alto , Principal Verification & Validation Engineer, Engineering , Palo Alto, California