Senior Process Control Engineer

1 month ago


Palo Alto, California, United States Recor Medical Full time
About the Role

We are seeking a highly skilled Senior Process Control Engineer to join our team at Recor Medical. As a key member of our process control group, you will be responsible for driving advancements in process and reliability control across both on-site and off-site manufacturing environments.

Key Responsibilities
  • 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.
  • 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.
  • Collaborate with cross-functional teams in characterization measurement equipment, including leading gage R&R and equipment capability analysis.
  • 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.
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.
  • 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.
What We Offer

Competitive salary range: $108,600 - $140,975 a year. Commensurate with experience, skills, education, and training.



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