Project Manager – Medical Device

JOB #

33351

Job Description

Nanox-X is looking for an experienced and highly motivated technologists Software Group manager who possesses technical depth and strong interpersonal skills. Nanox-X is a Medical Device company developing manufacturing and market an innovative X-Ray technology based on a Cloud platform and multi-functional medical device embedded software components which together will create the next generation of world-class X-Ray machine services. As the Program Manager, you will be responsible to manage New Product Introduction projects. This will require your leadership of cross-functional teams in a multi-site organization, developing Medical Devices. As the Project Manager, you will be responsible for the planning, scheduling, and executing projects within the framework of FDA/CE Quality System Regulations and under FDA/CE Design Controls.

Responsibilities

Create work breakdown structures, budgets, and timelines
Lead cross functional teams - Marketing, Clinical, Sales,Training, R&D, Operations, Quality, Legal, Regulatory, and Purchasing
Manage the day-to-day activities of team members
Track project progress against plan
Manage the project budget and schedule
Identify project risks
Provide plans to mitigate those risks
Negotiate conflicts and resource constraints
Provide regularly reports progress to senior management

Requirements

B.A/B.Sc. in Electrical or Mechanical Engineering orBiotechnology required.
Advanced degree preferred.
7 years' experience in Project Management with progressively increasing managerial and technical roles
Proven track record of delivering complex projects on time and in budget
Certified PMI Project Management Professional- preferred
Product Development Experience in a Highly RegulatedEnvironment Required (medical Device Class II)
Knowledge in IEC62304, IEC60601, ISO14971
Strong interpersonal skills. Comfortable working with all levels in an organisation
Proficient in both written and oral communication skills both in Hebrew and English
Experienced with Microsoft project and office
Successfully lead a medical device project from concept to market in FDA regulated industry
Demonstrated strong planning and organizational skills

Nice to have

Medical device development and FDA experience
Familiarity with FDA Design Control Guidelines

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Send your CV to HR@nanox.vision