Senior Engineer, Process Control - Palo Alto California

Company: Recor Medical Inc.
Location: Palo Alto, California
Posted On: 11/17/2024

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 that requires a dynamic individual capable of adapting quality to shifting priorities and managing multiple projects concurrently. The ideal candidate will work cross-functionally to drive advancements in process and reliability control across both on-site and off-site manufacturing environments. By leveraging statistical analysis and data-driven methodologies, they will systematically characterize processes and develop robust control plans that ensure product quality in a fast-paced environment. This role reports directly to the Manager of Process Control Engineering.Responsibilities and Duties

• 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.$108,600 - $140,975 a yearCommensurate with experience, skills, education, and training.
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