Staff Manufacturing 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.
This position is responsible for process development of our ceramic manufacturing process. This process is used to produce our transducer which generates our ultrasound therapy. This is a hands-on position which includes process development and characterization, data analysis, working with suppliers and technology and supply roadmaps. Position reports to the Advanced Materials Engineering Manager. 

Responsibilities and Duties

• Designs and qualifies tooling, fixtures, and equipment. This may involve varying degrees of automation. 
• Leads process characterization and improvement activities (screening experiments, Test Method Validation design and protocol writing, DOE, process mapping for inputs/outputs, equipment design and selection).
• Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications. 
• Coordinates design requirement review with appropriate engineering/scientific personnel to ensure compatibility of processing methods. 
• Creates manufacturing documentation (SOP’s, MPIs and records). 
• Conceives and plans projects involving definition and selection of new concepts, equipment automation technology, and approaches in the processing or development of new or improved processes. 
• Leads and coordinates activities of technicians in support of equipment/process development, equipment/process trouble shooting, and custom equipment procurement. 
• Contributes to developing partnerships with new suppliers. Performs supplier qualifications.
• Demonstrates an in-depth understanding of and applies Design/Process Excellence tools; assists others in applying tools and methodology; Lead root cause analysis efforts to investigate component failures and direct cross functional team with appropriate mitigation strategies. Leads others in making data driven decisions and in taking actions in anticipation of the future; creates opportunities for the long term or avoids future issues.
• Utilizes time management techniques to better balance workload; identifies ways to enhance the way work is done to save time and enhance efficiency; transmits sense of urgency based on business needs. Identifies resource allocation requirements needed to implement priorities. 
• Leads complex functional projects to achieve project deliverables; renegotiates with management to overcome project challenges.
• Evaluate potential risks associated with components and develop strategies to mitigate these risks throughout the supply chain.
• Review product demand plans and make recommendations for supply assurance.
• Conduct or supervise tests on raw materials or finished products to ensure quality.
• Analyze product failure data and lab test results in order to determine causes of problems and develop solutions.
• Anticipates potential safety hazards; recommends solutions; understands US and international safety and environmental requirements.
• Drive the implementation changes by generating and executing test plans, test method development, verification, and validation protocols. Develop reports and conclusions that have an impact across the company; gain alignment with management on complex justifications.
• Demonstrates technical expertise and supports regulatory by providing technical justifications for submissions. Supports the regulatory submission process in compliance with all ISO, EN MDD and FDA regulations and requirements. 

Requirements

• Bachelor’s degree in engineering: Mechanical, Industrial, Manufacturing and Process disciplines will be considered.
• A minimum of 8+ years’ relevant engineering experience
• Excellent oral and written communication skills. 
• Experience with complex data analysis using JMP, MiniTab, or other yield tools.
• Proven record of product engineering leadership resulting in quantifiable improvements in quality, yield, cost or process.

COVID-19 vaccination requirementsAt 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