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.

This is a hands-on position which will lead the advancement of equipment controls and readiness activities for Recor manufacturing to ensure product quality, operational efficiency, and support data-driven decisions. Position reports to the Sr Manager, Process Control and may supervise technicians and engineers.

Responsibilities and Duties

• Duties and responsibilities include, but are not limited to
• Manage the control of equipment design, qualification, and maintenance processes to fit cross-functional needs.

• Create, develop, and improve equipment control procedures and processes.
• Build and manage a team to execute equipment controls, including: Equipment monitoring requirements; Preventive maintenance, calibration, repair; Equipment qualification; CER maintenance and monitoring

• Manage the support of equipment-related engineering objectives, including: Collaborating with Production and Engineering to drive continuous improvement initiatives; Drive the development of custom equipment, including definition, acceptance testing, and qualification; Qualification of duplicate equipment

• Identify and seek feedback from other functions to develop scalable and efficient equipment control solutions.
• Responsible for the investigation into causes of equipment failures and anomalies, and decisions regarding the mitigations. 
• Collaborate with Production to monitor equipment downtime.
• Responsible for implementing measures to reduce equipment downtime.
• Must execute work in a manner complaint with FDA and ISO regulations for medical device development and manufacture.
• Ensure the professional development of individual team members is planned and completed.
• Establish group and individual objectives, priorities, and metrics.
• Contribute to project planning and budgeting process.
• Must be a cooperative, engaged, hands-on leader.

• Bachelor of Science in Engineering or related field preferred
• Must have 8 years of experience in a regulated environment such as medical devices. 
• Minimum 3 years management experience.
• Proven track record of equipment development and implementation for volume production.
• Proven record of engineering leadership resulting in quantifiable improvements in quality, yield, cost, or process.
• Exhibit good problem solving and analytical skills. 
• Must have the ability to multi-task in a fast-paced environment and respond to changing priorities.
• Excellent communication and organization skills.

COVID-19 vaccination requirements

At Recor Medical, we care, we collaborate, we challenge, and we create. Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID-19 vaccines will be required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine.

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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