Senior Engineer, Process Control

September 10

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Pioneers of Ultrasound Renal Denervation (uRDN) to treat hypertension

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Description

•Conduct hands-on characterization, qualification, documentation and implementation of manufacturing processes, equipment and tooling. •Develop methods for the testing and monitoring of processes, technologies, and products to ensure consistent product quality from both contract manufacturers and internal manufacturing (such as statistical process controls). •Analyze process and production data to identify issues; design and conduct experiments to uncover root causes. Implement corrective actions and manage verification plans to ensure their effectiveness. •Develop and implement comprehensive reliability characterization and reliability testing strategies to ensure product durability and performance. •Perform reliability tests, generate engineering reports, and update risk management documentation. •Collaborate with cross-functional teams in characterization measurement equipment, including leading gage R&R and equipment capability analysis. •New product scale-up, process optimization, technology transfer and process validation activities. •Participate in the creation and continuous improvement of production procedures and product specifications to enhance and optimize process controls. •Engage with cross-functional teams to develop scalable control systems for operational processes. •Support production capacity and yield improvement activities. •Assist in qualification of alternative supply sources or new vendors. •May research and implement new methods and technologies to enhance operations. •Must execute work in a manner compliant with FDA and ISO guidelines for medical device development and manufacture. •Any additional duties as assigned

Requirements

•Bachelor of science degree in engineering or related technical disciplines •Minimum 5 years in a regulated manufacturing environment such as medical devices with an understanding of domestic and international regulatory standards (i.e. FDA QSR, ISO 13485 and MDD/MDR). •Proficient knowledge of design controls, process validation, statistics, reliability analysis, and design of experiments. •Effective verbal and written communication skills; ability to write clear procedures. •Strong problem solving and analytical skills. •Self-motivated, collaborative, and result oriented. •Proficient in statistical software such as JMP or Minitab. •Proficient in the use of Microsoft Office Suite. •Experience in supplier management and/or contract manufacturing control preferred. •Willingness to travel up to 15% domestically