Project Manager

AccuLine is a medical device startup founded in early 2022 with a vision to save the lives of millions of people worldwide by preventing the next heart attack.

AccuLine is developing CORA - a fast, accurate, non-invasive, inexpensive, and user-friendly examination for the early detection of coronary artery disease, aiming to replace inaccurate stress test exams.

Our technology is based on the discovery of two bio-signals in the heart’s electrical activity and deep learning analysis of several vital signs during a 4-minute exam. The exam can be performed easily by any medical staff personnel in any setting, and the results are provided immediately.

AccuLine received two grants from the Israeli Innovation Authority, and among our shareholders are eHealth Ventures, Maccabi Healthcare Services, and Mayo Clinic.

This is a unique opportunity to join the company at its early stages as one of its first employees, where you will be entrusted with the crucial task and the resources needed to shape the creation of a game-changing product with the potential to positively impact millions of lives.

Position Overview

The Project Manager will play a pivotal role in spearheading the development of CORA. This position requires a seasoned professional with a background in the MedTech vertical.

The Project Manager will work closely and collaborate with various internal stakeholders to drive the successful development and commercialization of CORA.

This role offers a unique opportunity to make a significant impact in revolutionizing the prevention of heart attacks and improving global healthcare outcomes.

Job description

• Establish, lead, and oversee the R&D efforts for CORA, collaborating with external HW & SW development vendors to drive product innovation and advancement.
• Define project objectives, timelines, and deliverables in alignment with company goals and regulatory requirements.
• Manage the R&D processes from concept to commercialization, ensuring adherence to quality standards, regulatory guidelines, and industry best practices.
• Document all phases of the R&D process, including design specifications, test protocols, and validation procedures, in compliance with regulatory standards.
• Collaborate with QA teams to ensure the implementation of robust quality systems and procedures throughout the R&D lifecycle.
• Work closely with cross-functional teams, including engineering, regulatory affairs, clinical affairs, and marketing, to integrate R&D efforts into overall product development strategy.

Job Requirements

• Bachelor's or master's degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, or a related field.
• 5+ years of experience in a similar role within the MedTech vertical (preferably in a startup company)
• Proven track record as R&D projects lead from concept to commercialization in a regulated environment (e.g., FDA, ISO standards).
• Experience in development of a system that included both hardware and a user interface.
• Experience in writing SOPs, DMR, DHR, MRD & IFU documents.
• Excellent project management skills, with the ability to prioritize tasks, manage resources, and meet project milestones and deadlines.
• Experience working with external vendors, with a focus on achieving project objectives.
• Strong communication and interpersonal skills, with the ability to effectively communicate complex technical concepts to diverse stakeholders.
• Ability to thrive in a fast-paced, dynamic startup environment, with a passion for innovation and making a positive impact in healthcare.
• Ability to work collaboratively with a "can-do" attitude in a small company environment.
• Organized and detail-oriented.

Location - Petah-Tikva