Project Manager

2 weeks ago

Tel Aviv, Tel Aviv, Israel LuminX (Formerly Dentlytec) Full time

Overview

LuminX is a pre commercial medical device company in the dental space with offices in Israel and the US, developing next-generation intraoral scanning and periodontal diagnostic devices that combine advanced optics, AI, and smart workflows to improve chairside efficiency and patient outcomes.

We are seeking a highly organized and proactive Project Manager to lead cross-functional initiatives from planning through execution. The ideal candidate will have strong leadership skills, proven project management experience, and the ability to deliver results within scope, budget, and timeline.

What You'll Do

· Define project scope, goals, and deliverables in alignment with business objectives.

· Lead cross-functional teams and coordinate internal and external stakeholders

· Identify, assess, and mitigate project risks.

· Collaborate with team leaders to define clear milestones and track progress against company goals.

· Track progress and prepare status reports for leadership and stakeholders.

· Ensure compliance with company policies, regulatory requirements, and industry best practice.

· Support preparation of documentation for regulatory milestones (e.g., ISO 13485 compliance, FDA 510(k), CE submissions).

· Partner with clinical teams to support study planning and execution.

Requirements

· Bachelor's degree in business, engineering, or related field.

· years of project management experience in complex HW/SW integrated medical devices.

· Strong knowledge of project management methodologies (Agile, Waterfall, or hybrid) and tools (e.g., Jira/Confluence, Smartsheet/MS Project, requirements and risk management tools).

· Excellent communication and problem-solving skills; fluent in Hebrew and English.

· Familiarity with regulatory environments (FDA, CE marking, ISO and associated testing requirements.

Nice-to-Haves

· Experience contributing to FDA 510(k) submissions or EU MDR interactions.

· Familiarity with quality standards such as ISO risk management), IEC software lifecycle), IEC usability), and ISO biocompatibility).

· Exposure to NPI/operations (supplier qualification, process validation, DFM/DFA).

· Technical degree in engineering, computer science, or related field.

· Experience with imaging/optics, AI/ML in regulated products, or dental devices/intraoral scanners.

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