Norbert Leinfellner

Norbert Leinfellner Email and Phone Number

Proven R&D and PMO Leader in the medical device industry. I have built amazing teams. My North Star is "Sustainable Growth". Innovation is my engine. @ CAIRE Inc.
Norbert Leinfellner's Location
San Francisco Bay Area, United States, United States
Norbert Leinfellner's Contact Details

Norbert Leinfellner personal email

n/a
About Norbert Leinfellner

I am a proven leader with strong record of building high-performance teams that deliver safe, effective, and innovative medical devices. Demonstrated expertise in program management, global organizational planning, cross-functional relationship management, sustaining and value engineering, and all phases of product development in multiple clinical spaces. Core Competencies• Delivering Innovation – Drove realization of a best in class three-dimensional video ultrasound machine, industry’s first Optical Coherence Tomography (OCT) engine as a platform, and pre-development of the first US FDA cleared swept-source OCT posterior ocular imaging device. Drove multi-product DHF remediation. Passion for delivering on ideas thought to be impossible.• Managing Complexity – Led global technology & product development teams in multiple diagnostic and treatment spaces. Responsible for new product development under design control, value engineering, and sustaining engineering. Deep expertise in technology conceptualization and product development.• Driving Execution & Results – Strong program and project management and risk management skills. Deep understanding of medical device design control process and FDA regulation. Creative, collaborative and engaging problem solver. Ensure market readiness, including clinical & regulatory. • Building strong teams – 15+ years leading global, culturally diverse teams. Enjoy the challenge of empowering, engaging, developing and motivating team members and reports. Strong track record for leading change and building effective teams in a global matrix organization.• Personal Traits – I embrace change and challenge, thrive in ambiguity, prefer to wear many hats, exhibit high emotional intelligence and seek entrepreneurial, “hands on” environment with similarly motivated and accountable individuals.

Norbert Leinfellner's Current Company Details
CAIRE Inc.

Caire Inc.

View
Proven R&D and PMO Leader in the medical device industry. I have built amazing teams. My North Star is "Sustainable Growth". Innovation is my engine.
Norbert Leinfellner Work Experience Details
  • Caire Inc.
    Executive Vice President, Global Engineering
    Caire Inc. Sep 2024 - Present
    Ball Ground, Georgia, Us
  • Inogen
    Vice President, Engineering
    Inogen Jan 2023 - Sep 2024
    Goleta, California, Us
  • Element Science, Inc.
    Head Of Pmo
    Element Science, Inc. Aug 2020 - Jan 2023
    San Francisco, Ca, Us
    Element Science is an innovative San Francisco-based medical device and digital health company focused on developing solutions at the intersection of clinical-grade wearable devices, machine learning algorithms and lifesaving therapies to address the needs of high-risk cardiovascular patients, primarily as they transition from the hospital to home.The company was founded in 2011 by Uday Kumar, MD, a cardiac electrophysiologist by training, and founder of iRhythm Technologies (NASD: IRTC), a leading digital healthcare company focused on cardiac rhythm diagnosis.Element Science is developing a proprietary next-generation wearable digital platform that unites patient centric human factor engineering, sophisticated machine learning algorithm development principles, and rigorous electromechanical medical device development standards. The platform will address leading causes of death and hospitalization due to heart disease. The first product, an unobstructive, low-profile personal wearable defibrillator, aims to redefine the treatment for temporary periods of elevated Sudden Cardiac Death (SCD) risk.
  • Fresenius Medical Care
    Vice President, R&D And Pmo
    Fresenius Medical Care Feb 2016 - Aug 2020
    Bad Homburg, Frankfurt, De
    Led the R&D in the Product Engineering Center Machines North America with a budget of 30 Mio + USD• Executed product development programs for hemodialysis and peritoneal dialysis products • Drove cultural change to build a high-performance team of 150 engineers and project managers• Implemented matrix organization, led PMO, and ensured on-time delivery of 50+ projects/year, zero production-line-down events, executed companywide DHF remediation, created System Verification and Portfolio Management departments
  • Fresenius Medical Care
    Director Program Management
    Fresenius Medical Care Apr 2015 - Feb 2016
    Bad Homburg, Frankfurt, De
    • Led the execution of Dialysis product development• Planned, built, and released innovative product updates and 510(k) submissions. Managed projects through all phases of product development. Budget: 2 Mio+ USD• Led global, cross-functional teams• Drove DHF remediation and catch-up 510(k) projects and delivered on time on budget
  • Carl Zeiss Meditec
    Senior Manager, R&D
    Carl Zeiss Meditec Feb 2014 - Apr 2015
    Jena, De
    • Led the implementation of the Business sector’s roadmap. • Built and grew a department of program managers. Coordinated projects world-wide between sites in Germany, India, and USA• Planned, built, and commercialized highly innovative retina scanning devices. Budget: 20 Mio+ USD• Operated within strict budget restrictions and high-quality demand• Delivered new Cirrus release with Premium Anterior Segment Package at AAO 2014. Planned all releases for AAO 2015
  • Carl Zeiss Meditec
    Program Manager
    Carl Zeiss Meditec Jan 2009 - Jan 2014
    Jena, De
    • Executed product development programs • Managed projects through all phases of product development (feasibility, design and verification, sustaining engineering, and cost reduction) following GMP and ISO 9001:2008 processes. Budget: 9 Mio+ USD• Managed project dependencies on global business needs, managing technical risk during execution phase, organizational matrix challenges• Delivered products and concept prototypes with measured process capabilities
  • Siemens Healthcare
    Software Program Manager
    Siemens Healthcare Mar 2003 - Dec 2008
    Forchheim, De

Norbert Leinfellner Skills

Medical Devices Software Project Management Cross Functional Team Leadership Product Management Product Development Agile Methodologies Software Development Program Management Management R&d Product Launch Project Management Dicom Biomedical Engineering Medical Imaging Erp Change Management Scrum Digital Imaging Requirements Analysis Product Lifecycle Management Iso 13485 Process Improvement Software Engineering Design Control Fda Electronics Engineering Management Testing Agile Project Management Leadership Risk Management Pacs Capital Equipment Research And Development Agile Product Life Cycle Management Image Processing Hl7 Iso 14971 Hardware Diagnostics U.s. Food And Drug Administration Business Process Improvement Eai V&v

Norbert Leinfellner Education Details

  • University Of St.Gallen
    University Of St.Gallen
    Strategic Management
  • Technical University, Graz (Austria)
    Technical University, Graz (Austria)
    Physics
  • Technical University, Graz (Austria)
    Technical University, Graz (Austria)
    Physics

Frequently Asked Questions about Norbert Leinfellner

What company does Norbert Leinfellner work for?

Norbert Leinfellner works for Caire Inc.

What is Norbert Leinfellner's role at the current company?

Norbert Leinfellner's current role is Proven R&D and PMO Leader in the medical device industry. I have built amazing teams. My North Star is "Sustainable Growth". Innovation is my engine..

What is Norbert Leinfellner's email address?

Norbert Leinfellner's email address is no****@****gmx.net

What schools did Norbert Leinfellner attend?

Norbert Leinfellner attended University Of St.gallen, Technical University, Graz (Austria), Technical University, Graz (Austria).

What are some of Norbert Leinfellner's interests?

Norbert Leinfellner has interest in Dance, Art, Golf, See 5, Children, Skiing, Electronics, Education, Science And Technology, Music.

What skills is Norbert Leinfellner known for?

Norbert Leinfellner has skills like Medical Devices, Software Project Management, Cross Functional Team Leadership, Product Management, Product Development, Agile Methodologies, Software Development, Program Management, Management, R&d, Product Launch, Project Management.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.