Technical Project Manager

Posted 18 Days Ago
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Yokneam, ISR
In-Office
Senior level
Healthtech • Biotech
The Role
The Technical Project Manager will plan and execute medical device development projects, leading R&D teams and managing project lifecycles, timelines, and compliance with regulations.
Summary Generated by Built In
Description

About the role:       

Lumenis is a fast-growing, global leader in energy-based solutions for Aesthetics and Eye-Care. We are based in Yokneam, Israel (with offices in Tel-Aviv) with a strong business performance worldwide.

We are looking for a Technical Project Manager for the Vision Business Unit, which includes a broad portfolio of leading solutions in the market as well as an exciting innovation pipeline. The PM holds responsibility for the planning and execution of medical device development projects within Lumenis Vision R&D department, from requirements to release, leading cross-functional R&D teams and interfacing dep. of Engineering, QA, RA, Service, sub-contractors and manufacturing sites.

The PM is accountable for the full project lifecycle - planning, synchronizing and monitoring  to meet performance, quality, reliability, manufacturability, serviceability  cost, and time to market KPIs, all in accordance to the medical regulations and to Lumenis standard operation procedures.

Key Responsibilities

  • Responsible for the project Planning (DDP) including constraints and dependencies, resource plan, critical path (GANTT), milestones, development risks and mitigations.
  • Responsible for Project lifecycle events – Gates, Checklists, Design Reviews, version releases, V&V readiness, NPI and Transfer to Production readiness.
  • Lead the project's PLM activities (ECOs, CAs, etc.) in cooperation with the NPI engineer.
  • Define and maintain the projects GANTT, JIRA/SCRUM sprints plans and/or other project management tools and methodologies.
  • Synchronize the  project's cross-functional technical teams and subcontractor holding recurring project meetings.
  • Continuously track and report project progress to the relevant stakeholders, perform task prioritization, define recovery/remedial actions when needed and drive effective problem resolution to enable efficient execution of the project.
  • Serve as the primary project representative in audits, inspections, CAPAs handling and formal reviews.
Requirements
  • B.Sc. / B.E. in Engineering or a related technical field.
  • 5+ years of experience in technical project management or R&D leadership roles.
  • Proven experience leading regulated medical device development projects.
  • Proficient with agile and waterfall methodologies
  • Proficient with Project management tools and methodologies, Jira SCRUM/CANBAN and development PLM tools (ENOVIA)
  • Strong cross-functional leadership, planning, and communication skills.

Core Competencies

  • End-to-end ownership and accountability.
  • Risk-based decision making in regulated environments.
  • Strong leadership in matrix organizations.
  • Ability to manage complex, multidisciplinary projects.
  • Clear communication with project stakeholders.
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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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