Heartflow is a medical expertise firm advancing the prognosis and administration of coronary artery illness, the #1 explanation for dying worldwide, utilizing cutting-edge expertise. The flagship product—an AI-driven, non-invasive cardiac check supported by the ACC/AHA Chest Ache Tips referred to as the Heartflow FFRCT Evaluation—offers a color-coded, 3D mannequin of a affected person’s coronary arteries indicating the influence blockages have on blood circulation to the guts. Heartflow is the primary AI-driven non-invasive built-in coronary heart care answer throughout the CCTA pathway that helps clinicians establish stenoses within the coronary arteries (RoadMap™Evaluation), assess coronary blood circulation (FFRCT Evaluation), and characterize and quantify coronary atherosclerosis (Plaque Evaluation). Our pipeline of merchandise is rising and so is our workforce; be a part of us in serving to to revolutionize precision heartcare.
Heartflow is a VC-backed firm that has acquired worldwide recognition for distinctive strides in healthcare innovation, is supported by medical societies all over the world, cleared to be used within the US, UK, Europe, Japan and Canada, and has been used for greater than 400,000 sufferers worldwide.
The Senior High quality Engineer is a part of the High quality and Regulatory Affairs workforce. The person has 6-8 years of expertise in medical gadget high quality with an understanding of high quality necessities and might resolve a variety of points whereas sustaining compliance with laws and requirements. This particular person will play a key position in HeartFlow high quality actions involving cross-functional collaboration for product modifications, in addition to upkeep of high quality administration system documentation. #LI-Distant; #LI-IB1
Job Duties:
- Assist frequent minor software program releases by performing threat assessments and aiding regulatory groups in establishing higher processes for threat administration
- Collaborate with cross-functional groups to drive high quality undertaking administration actions
- Handle audits (inner and exterior) and talk non-conformities assessed to higher workforce, driving the implementation of change when wanted
- Collaborate with exterior companions together with regulatory companies, licensed representatives, importers and distributors to assist administration of High quality Techniques
- Present enter to the danger administration course of to make sure dangers are recognized and up to date throughout the product life cycle
- Conduct High quality evaluation of modifications to requirements and laws and talk cross-functionally
- Assist and drive High quality System administration and implementation of modifications
- Assist Corrective and Preventative Motion (CAPA) processes and non-conformances (NCRs) by identification of root trigger
- Practice firm in assist of High quality initiatives
- Different related duties as assigned
- Capability to work in a fast-paced adaptive setting, self-starter, and robust workforce participant
Expertise Wanted:
- Expertise working with SaMD and AI / ML gadgets a should
- Excessive competency of ISO 13485, ISO 14971, 21 CFR 820
- Expertise with threat administration actions together with threat evaluation and assessment of FMEAs
- Mission administration abilities
- Demonstrated workforce collaboration
- Wonderful communication, writing, and modifying abilities
- Sturdy Phrase, Excel, and PowerPoint abilities
- Entrance room audit expertise required.
Instructional Necessities & Work Expertise:
- Bachelor’s diploma in science, engineering, or equal
- 6-8 years of expertise within the medical gadget business with a deal with High quality
- Licensed High quality Auditor a plus
- Expertise with software program as a medical gadget with a deal with synthetic intelligence and machine studying
This place has an estimated base wage of $115,000 – $160,000, a money bonus, and inventory choices. #LI-IB1; #LI-Distant
Heartflow is an Equal Alternative Employer. We’re dedicated to a piece setting that helps, conjures up, and respects all people and don’t discriminate in opposition to any worker or applicant due to race, colour, faith, marital standing, age, nationwide origin, ancestry, bodily or psychological incapacity, medical situation, being pregnant, genetic data, gender, sexual orientation, gender id or expression, veteran standing, or another standing protected underneath federal, state, or native regulation. This coverage applies to each facet of employment at Heartflow, together with recruitment, hiring, coaching, relocation, promotion, and termination.
Positions posted for Heartflow aren’t meant for or open to 3rd occasion recruiters / companies. Submission of any unsolicited resumes for these positions will probably be thought of to be free referrals.