Senior Quality Engineer

Heartflow; United States; Remote; USD 115,000 - 160,000; Full time

Job summary

Join a forward-thinking medical technology company dedicated to revolutionizing heart care. As a Senior Quality Engineer, you will leverage your expertise in quality management and regulatory compliance to enhance product quality and safety. This role offers the opportunity to work on cutting-edge AI-driven technologies that improve patient outcomes. Collaborate with cross-functional teams and external partners to drive quality initiatives and manage audits. If you are passionate about making a difference in healthcare and thrive in a dynamic environment, this position is perfect for you.

Qualifications

• 6-8 years of experience in medical device quality with compliance knowledge.
• Experience with software as a medical device focusing on AI/ML.

Responsibilities

• Support software releases by performing risk assessments.
• Manage audits and communicate non-conformities to the team.
• Collaborate with external partners to support Quality Systems.

Skills

SaMD and AI / ML devices

ISO 13485

ISO 14971

21 CFR 820

Risk management activities

Project management

Team collaboration

Communication skills

Word, Excel, PowerPoint

Front room audit experience

Education

Bachelor’s degree in science or engineering

6-8 years of experience in medical device industry

Certified Quality Auditor

Job description

Heartflow 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 FFRCTAnalysis—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 (RoadMapAnalysis), assess coronary blood flow (FFRCTAnalysis), 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 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 400,000 patients worldwide.

The Senior Quality Engineer is part of the Quality and Regulatory Affairs team. The individual has 6-8 years of experience in medical device quality with an understanding of quality requirements and can resolve a wide range of issues while maintaining compliance with regulations and standards. This individual will play a key role in HeartFlow quality activities involving cross-functional collaboration for product changes, as well as maintenance of quality management system documentation. #LI-Remote; #LI-IB1

Job Responsibilities:

• Support frequent minor software releases by performing risk assessments and aiding regulatory teams in establishing better processes for risk management
• Collaborate with cross-functional teams to drive quality project management activities
• Manage audits (internal and external) and communicate non-conformities assessed to greater team, driving the implementation of change when needed
• Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors to support management of Quality Systems
• Provide input to the risk management process to ensure risks are identified and updated during the product life cycle
• Conduct Quality assessment of changes to standards and regulations and communicate cross-functionally
• Support and drive Quality System management and implementation of changes
• Support Corrective and Preventative Action (CAPA) processes and non-conformances (NCRs) through identification of root cause
• Train company in support of Quality initiatives
• Other relevant duties as assigned
• Ability to work in a fast-paced adaptive environment, self-starter, and strong team player

Skills Needed:

• Experience working with SaMD and AI / ML devices a must
• High competency of ISO 13485, ISO 14971, 21 CFR 820
• Experience with risk management activities including risk assessment and review of FMEAs
• Project management skills
• Demonstrated team collaboration
• Excellent communication, writing, and editing skills
• Strong Word, Excel, and PowerPoint skills
• Front room audit experience required.

Educational Requirements & Work Experience:

• Bachelor’s degree in science, engineering, or equivalent
• 6-8 years of experience in the medical device industry with a focus on Quality
• Certified Quality Auditor a plus
• Experience with software as a medical device with a focus on artificial intelligence and machine learning

This position has an estimated base salary of $115,000 - $160,000, a cash bonus, and stock options. #LI-IB1; #LI-Remote

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.