Principal Systems 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 Systems Engineer leads system-level architecture, requirements development, and integration activities for complex medical device products. This role ensures robust systems engineering practices throughout the product lifecycle while coordinating cross-functional teams to deliver innovative medical solutions that meet user needs and regulatory requirements.

Responsibilities and Duties: 
•    Lead system architecture development and technical strategy 
•    Drive requirements management and traceability 
•    Develop and maintain system-level specifications 
•    Lead system integration and verification activities
•    Coordinate cross-functional development teams 
•    Maintains working knowledge of IEC 60601, IEC 62304, IEC 62366 and related standards
•    Perform system-level risk analysis and management 
•    Guide subsystem interface definitions and controls 
•    Lead technical reviews and design reviews 
•    Develop system verification and validation strategies 
•    Support regulatory submissions with systems documentation
•    Mentor engineers in systems engineering practices 
•    Drive resolution of complex technical issues 
•    Ensure compliance with design controls 
•    Manage system-level change control 
•    Support post-market surveillance activities 
•    Lead system FMEA activities 
•    Develop and maintain system models 
•    Coordinate with external development partners 
•    Supports regulatory & Quality function
•    Guide technology assessment and selection 
•    Lead system-level troubleshooting efforts

Technical Requirements:
•    BS/MS in Systems Engineering, Biomedical, or related field 
•    10+ years experience in medical device development 
•    Expert knowledge of systems engineering principles
•     Strong background in requirements management 
•    Experience with risk management (ISO 14971) 
•    Knowledge of design controls (FDA, ISO 13485) 
•     Expertise in verification and validation 
•    Experience with system modeling tools
•    Strong problem-solving abilities 
•    Project management experience 
•    Experience with combination products

 Required Skills: 
•    Strong analytical and problem-solving abilities 
•    Excellence in cross-functional leadership 
•    Strong technical writing capabilities 
•    Project management expertise 
•    Risk assessment and management
•    Requirements analysis and management 
•    System architecture development 
•    Design control experience 
•    Verification planning and execution 

Preferred Qualifications:
•    PH. D in related field
•    Experience with software-intensive systems
•    Background in systems modeling 
•    Six Sigma certification 
•    Medical device startup experience
 

Salary Range: $206,479- $247,000 (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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