Norbert Leinfellner Email and Phone Number
Norbert Leinfellner work email
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Norbert Leinfellner personal email
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.
Caire Inc.
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Executive Vice President, Global EngineeringCaire Inc. Sep 2024 - PresentBall Ground, Georgia, Us -
Vice President, EngineeringInogen Jan 2023 - Sep 2024Goleta, California, Us -
Head Of PmoElement Science, Inc. Aug 2020 - Jan 2023San Francisco, Ca, UsElement 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. -
Vice President, R&D And PmoFresenius Medical Care Feb 2016 - Aug 2020Bad Homburg, Frankfurt, DeLed 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 -
Director Program ManagementFresenius Medical Care Apr 2015 - Feb 2016Bad 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 -
Senior Manager, R&DCarl Zeiss Meditec Feb 2014 - Apr 2015Jena, 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 -
Program ManagerCarl Zeiss Meditec Jan 2009 - Jan 2014Jena, 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 -
Software Program ManagerSiemens Healthcare Mar 2003 - Dec 2008Forchheim, De
Norbert Leinfellner Skills
Norbert Leinfellner Education Details
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University Of St.GallenStrategic Management -
Technical University, Graz (Austria)Physics -
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.
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