Senior Quality Engineer

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

Job summary

An innovative medical technology company is seeking a Senior Quality Engineer to join their Quality and Regulatory Affairs team. This role is pivotal in ensuring compliance with quality standards while driving cross-functional collaboration on product changes. The ideal candidate will have a strong background in medical device quality, particularly with AI-driven solutions. You'll be part of a dynamic environment where your contributions will directly impact the management of coronary artery disease, ultimately improving patient care. If you're ready to make a difference in healthcare innovation, this opportunity is for you.

Qualifications

• 6-8 years of experience in medical device quality.
• Understanding of quality requirements and compliance regulations.

Responsibilities

• Support software releases and risk assessments.
• Manage audits and communicate non-conformities.
• Collaborate with regulatory agencies and partners.

Skills

SaMD and AI/ML devices

ISO 13485

ISO 14971

21 CFR 820

Risk management activities

Team collaboration

Communication skills

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Education

Bachelor’s degree in science or engineering

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 FFR CT 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 (RoadMapAnalysis), assess coronary blood flow (FFR CT 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 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
• Demonstrated team collaboration
• Excellent communication, writing, and editing skills
• Strong Word, Excel, and PowerPoint skills

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.

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