Offer summary

Qualifications:

Bachelor’s degree in science, engineering, or equivalent., 6-8 years of experience in the medical device industry with a focus on Quality., High competency in ISO 13485, ISO 14971, and 21 CFR 820., Experience with software as a medical device, particularly in AI and ML..

Key responsibilities:

Support software releases by performing risk assessments and improving risk management processes.

Collaborate with cross-functional teams on quality project management activities.

Manage audits and communicate non-conformities to the team, driving necessary changes.

Conduct quality assessments of changes to standards and regulations, ensuring compliance.

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_CTAnalysis—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 (FFR_CTAnalysis), 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.

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