Project Manager

Reposted 2 Days Ago
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Hiring Remotely in Israel
Remote
Mid level
Healthtech • Biotech
The Role
The Project Manager is responsible for managing multidisciplinary medical device development projects from initiation to market release, ensuring technical execution and regulatory compliance.
Summary Generated by Built In

About Pollogen & Lumenis

Skincare technology expert Pollogen is a dynamic subsidiary of Lumenis, a global pioneer in energy-based technology for the aesthetics and vision domains with sales in nearly 100 countries, a large and growing installed-base, and strong presence in the US, Europe, and Asia. Pollogen offers a fresh approach to innovation, specializing in professional-grade and home-use devices that provide real results. Combined with Lumenis’ six decades of market leadership, 330+ patents, 500+ clinical publications, Pollogen and Lumenis offer the perfect balance of scientific artistry and creative excellence.

Basic Job Purpose

The Project Manager is accountable for end-to-end delivery of multidisciplinary medical device development projects, ensuring alignment between business needs, technical execution, regulatory compliance, and product lifecycle objectives.

Key Responsibilities

  • Full ownership of product development projects from initiation through market release and lifecycle management
  • Planning and execution of project scope, budget, resources, milestones, and schedules
  • Close collaboration with Product, Business Development, and Marketing to translate market and customer needs into technical deliverables
  • Leadership of multidisciplinary teams, including R&D, software, regulatory, clinical, operations, and external subcontractors
  • Definition and control of system-level requirements, including hardware, software, and integration aspects
  • Continuous monitoring of execution, risks, dependencies, and mitigation plans, with proactive decision-making
  • Enforcement of medical device development processes, quality systems, and regulatory standards across all disciplines
  • Ownership of development documentation, including DHF, DMR, and software lifecycle documentation
  • Accountability for verification and validation activities at system, hardware, and software levels
  • Leadership of transition to manufacturing, including test strategies, production readiness, and change control
  • Support of regulatory submissions, safety testing, root cause analysis, and implementation of corrective actions

Required Qualifications

  • Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or equivalent engineering discipline (mandatory)
  • 3-5 years of proven experience managing multidisciplinary medical device development projects (mandatory)
  • Solid knowledge of medical device development processes, including design controls, V&V, documentation, and regulatory compliance
  • Strong system-level engineering mindset with ability to manage complex technical trade-offs
  • Practical, working understanding of software development lifecycle processes, including requirements management, architecture, implementation, testing, integration, configuration management, and change control
  • Experience working with software development tools and environments, including JIRA and Linux-based systems
  • High professional credibility, accountability, and data-driven decision-making capability
  • Excellent communication skills with experience working directly with senior leadership and multiple stakeholders

Advantage

  • Familiarity with IEC 62304 and regulated software development for medical devices
  • Experience with aesthetic or energy-based medical systems
  • Proven involvement in full product lifecycle and roadmap execution

Top Skills

JIRA
Linux-Based Systems
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The Company
San Jose, CA
1,437 Employees
Year Founded: 1966

What We Do

Energy to Healthcare

Lumenis is a global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology and Aesthetic markets, and is a world-renowned expert in developing and commercializing innovative energy-based technologies, including Laser, Intense Pulsed Light (IPL) and Radio-Frequency (RF).

For nearly 50 years, Lumenis'​ ground-breaking products have redefined medical treatments and have set numerous technological and clinical gold-standards. Lumenis has successfully created solutions for previously untreatable conditions, as well as designed advanced technologies that have revolutionized existing treatment methods in each and every one of the verticals we operate in.

Our drive for innovation stems from an uncompromising commitment to improving the health and well-being of our patients; addressing new and growing needs of aging populations; and in offering medical professionals cutting-edge solutions that fit seamlessly into the health-economics environment of the 21st century.

A Leader with Great Assets in Attractive Growing Markets

Innovative technology: Over 270 registered patents and more than 100 FDA clearances.
Global reach: Active installed base of more than 80,000 systems and presence in over 100 countries.

Strong brand: The Lumenis name and brand are associated with high quality among consumers.

Partnership with key opinion leaders (KOL’s): Strong KOL support and commitment to research and development.

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