Senior Engineer, Process Control

$108,600 - $140,975/Yr

Recor Medical - Palo Alto, CA

Full-time - Mid Level

Palo Alto, CA

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About the position

The position at Recor Medical involves pioneering Ultrasound Renal Denervation (uRDN) therapy aimed at treating hypertension. The role is hands-on and requires a dynamic individual who can adapt to shifting priorities while managing multiple projects. The candidate will work cross-functionally to drive advancements in process and reliability control in both on-site and off-site manufacturing environments, ensuring product quality through statistical analysis and data-driven methodologies.

Responsibilities

• Conduct hands-on characterization, qualification, documentation, and implementation of manufacturing processes, equipment, and tooling.
• Develop methods for testing and monitoring processes, technologies, and products to ensure consistent product quality from both contract manufacturers and internal manufacturing.
• 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.
• Engage in 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.
• Support production capacity and yield improvement activities.
• Assist in qualification of alternative supply sources or new vendors.
• Research and implement new methods and technologies to enhance operations.
• Execute work in compliance with FDA and ISO guidelines for medical device development and manufacture.

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.

Nice-to-haves

• Experience in supplier management and/or contract manufacturing control preferred.

Benefits

• Salary range of $108,600 - $140,975 a year, commensurate with experience, skills, education, and training.