Principal Reliability Engineer

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 Reliability Engineer is responsible for leading reliability engineering initiatives to ensure product quality, reliability, and compliance with regulatory requirements throughout the product lifecycle. This role will develop and implement reliability testing programs, analyze product performance data, and drive continuous improvement in product reliability for medical device systems

Responsibilities may include:
•    Design and execute reliability test plans and protocols for medical device products
•    Lead reliability analyses including FMEA, FTA, and reliability predictions
•    Develop reliability requirements and specifications for new products 
•    Analyze field performance data to assess product reliability and identify improvement opportunities 
•    Ensure adherence to the business Quality Management System through procedure compliance and internal audits 
•    Partner with R&D, Manufacturing, and Quality teams to implement reliability improvements
•    Establish reliability metrics and monitoring systems 
•    Lead investigation of reliability-related product complaints and failures 
•    Provide technical expertise in root cause analysis and corrective actions
•    Develop reliability test methods and maintain test equipment/systems 
•    Author technical reports and present findings to leadership 
•    Support regulatory submissions with reliability data and analyses
•    Create and maintain reliability-related procedures and documentation
•    Support design reviews with reliability assessments
•    Manage external testing laboratories and reliability consultants as needed

Requirements
•    Bachelor/MS in engineering (Mechanical, Electrical, Biomedical Preferred)
•    10+ years of reliability engineering experience in medical devices
•    10+ Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA) 
•    Experience in Safety Engineering, Reliability Engineering, Systems Engineering, Product Development Engineering, Clinical, or Field Support 
•    Ability to comprehensively apply degree-specific engineering principles in the design of highly reliable, complex systems
•    Proven track record of improving product reliability 
•    Expert knowledge of reliability engineering tools and statistical methods 
•     Experience with medical device regulatory requirements (FDA, ISO 14971, ISO 13485) 
•    Strong background in product development and manufacturing processes 
•    Proven track record of improving product reliability 
•     Excellence in technical writing and presentation skills 
•    Experience with reliability software tools and data analysis 
•    Strong project management 

Salary Range: $197,509- $239,295 (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.

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