Process Control Engineer

HeartFlow, Inc. is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the HeartFlow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. HeartFlow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.

HeartFlow is a VC-backed, pre-IPO company that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 250,000 patients worldwide.

The Process Control Engineer will own the non-conformance reporting process, support production with quality issues, establish and monitor quality metrics, implement corrective actions and support process validation and monitoring activities.

Job Responsibilities:

• Lead all activities for Non-Conformance Reports (NCR’s).
• Establish reliable processes; develop manufacturing processes and quality work instructions.
• Plan, lead, execute and complete projects to improve quality and efficiency.
• Work with process engineering team to guide monitoring of effectiveness in the product design lifecycle to ensure successful final transition of process/product into commercial.
• Extract and analyze data to measure quality and process performance and provide solutions for improvements.
• Work with the quality technician team to investigate and resolve production issues, nonconformances, CAPAs and complaints.
• Establish process and quality monitoring and evaluate data to ensure the process is in control.
• Create Tableau dashboards for monitoring production and production training processes
• Review and approve Process Failure Mode and Effects Analysis (pFMEA)
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Develop Product Risk Assessments for patient safety for CAPA’s and other projects.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Skills Needed:

• Requires a working knowledge of lean manufacturing concepts such as optimizing flow of product/process, value stream mapping and waste elimination.
• Understanding of statistical methods applied to quality.
• Experience with Minitab and/or Tableau preferred.
• Must understand QSR regulations 21 CFR Part 820, MDD Annex II and ISO 13485 and 14971
• Ability to write reports and effectively present information to all audiences, including management, and government or regulatory agencies
• Demonstrated ability to learn quickly and work in cross-functional teams.
• Strong communication, documentation and MS Office skills.

Educational Requirements & Work Experience:

• BS required / MS preferred in biomedical, industrial, mechanical engineering or other scientific or technical field
• Minimum of 3 years of experience in medical device environment

A reasonable estimate of the base salary compensation range is $64,000 and $148,000, cash bonus, and stock options.