Recor Medical
Principal Verification & Validation Engineer
Recor Medical, Palo Alto, California, United States, 94306
Principal Verification & Validation Engineer
Join to apply for the
Principal Verification & Validation Engineer
role at
Recor Medical Principal Verification & Validation Engineer
1 day ago Be among the first 25 applicants Join to apply for the
Principal Verification & Validation Engineer
role at
Recor Medical At 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 inspections
Requirements
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 abilities
Preferred 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 software
Salary 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 Opportunity
At 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 level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Recor Medical by 2x Get notified about new Verification Validation Engineer jobs in
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Join to apply for the
Principal Verification & Validation Engineer
role at
Recor Medical Principal Verification & Validation Engineer
1 day ago Be among the first 25 applicants Join to apply for the
Principal Verification & Validation Engineer
role at
Recor Medical At 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 inspections
Requirements
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 abilities
Preferred 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 software
Salary 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 Opportunity
At 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 level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Recor Medical by 2x Get notified about new Verification Validation Engineer jobs in
Palo Alto, CA . Cupertino, CA $165,500.00-$293,800.00 16 hours ago Manufacture and Test Engineer, Rack Integration
Cupertino, CA $165,500.00-$248,700.00 4 hours ago Sunnyvale, CA $68,077.00-$125,923.00 2 weeks ago Systems Verification & Validation Engineer/Scientist (Must Have Flow Cytomtery)
San Jose, CA $133,300.00-$186,800.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr