Kristen Luethje has been a Program Director in Bigfoot Biomedical since 2018. Furthermore, Kristen has professional experience at more than ten companies in the relevant field. Kristen has a total work experience of 18+ years. Kristen Luethje studied at the Stanford University from 1994 to 1995. Currently Kristen lives in Santa Clara, California region. You can find this person's actual phone and email through our search.
Name variants:
Kristina Luethje
Last updated May 31, 2024
Contact Information
Last Update
Jul 17, 2022
Email
ka**@hotmail.com
Location
Santa Clara, CA
Company
Workplace
Colleagues
Work History
Program Director
1820 Mccarthy Blvd, Milpitas, CA 95035
Directed all aspects of a complex program for the first commercial launch of a diabetes start-up which is developing products for optimizing the dosing and delivery of insulin. Led and coord...
from Jun 2018
Director of Program Management
1135 Obrien Dr, Menlo Park, CA 94025
Directed all projects for a Class III Medical Device start-up specializing in intraspinal neuromodulation therapy for pain management. Achieved successful PMA submission two months ahead of ...
Sep 2014 — Dec 2017
Senior Program Manager
9200 Xylon Ave north, Brooklyn Park, MN 55445
Program Manager for Contract Medical Device Manufacturer (OEM). Led large-scale development projects for complex Electro Mechanical medical devices with budgets of one to two million dollars...
Oct 2013 — Mar 2014
Contractor, Principal Project Manager
100 Boston Scientific Way, Marlborough, MA 01752
Project Manager for innovative medical device for aortic valve replacement. Led Process Validation to enable regulatory approval for commercialization in Europe. Directed efforts of over 25 ...
Feb 2013 — Sep 2013
Consultant, Senior Program Manager
33 Technology Dr, Irvine, CA 92618
Program Manager for numerous projects involving balloon catheters for a variety of applications. Responsible for project strategy and execution as well as a wide variety of specific function...
Feb 2011 — Nov 2012
Senior Project Manager
Sole Project Manager for 36-person Class III Medical Device start-up. Drove full reassessment of company’s PMA strategy resulting in a complete change in approach. Aligned Project content wi...
Aug 2009 — Dec 2010
Project Manager
100 Boston Scientific Way, Marlborough, MA 01752
Lead Project Manager for Quality Assurance Department. Senior-level responsibility for all Quality related aspects of major manufacturing site transfer of Class II/III Medical Device commerc...
Mar 2006 — Jan 2008
Project Manager
Led cross-functional teams of 30-40 professionals creating medical software releases with supporting hardware and peripherals for ultrasound systems used in medical imaging applications. Pro...
Apr 2002 — Apr 2005
Development Engineer
Managed high risk prototype development on a new transducer involving numerous state-of-the-art technology components, both material and process related. Successfully transferred product to ...
Jun 1999 — Apr 2002
Process Engineer
Led large-scale process and product improvement projects and supported manufacturing operations for Polymeric Positive Temperature Coefficient (PTC) devices. Projects had the following sign...
Aug 1995 — May 1999
Education
Sep 1994 — Jun 1995
Sep 1990 — Jun 1994
Occupations
Executive
Program Director
Project Managers
Director
Operations Manager
Skills
Cross Functional Team Leadership
Medical Devices
Product Development
Design Control
Program Management
Quality System
R&D
Iso 13485
Fda
Validation
Manufacturing
Engineering Management
Engineering
V&V
Project Management
Six Sigma
Testing
Start Ups
Process Simulation
Quality Assurance
Strategy
Continuous Improvement
Quality Control
Spc
Design of Experiments
Commercialization
Microsoft Project
Team Building
Strategic Planning
Process Validation
Budgeting
Risk Management
Verification and Validation
FAQs about Kristen Luethje
What is the main profession of Kristen Luethje?
Kristen Luethje is a Program Director.
What are the profession of Kristen Luethje?
These person's professions are Executive and Program Director
Where is Kristen Luethje currently located?
The expert is currently located in Santa Clara, California.
What is the professional's email?
The expert's email is ka**@hotmail.com.
Where did Kristen Luethje work?
Kristen Luethje worked at Bigfoot Biomedical, Spinal Modulation.
What education does Kristen Luethje have?
Kristen studied at the Stanford University from 1994 to 1995.
Are there any special industries Kristen Luethje is connected to?
Kristen Luethje works in Medical Devices industry.
Are there any professional skills, that Kristen Luethje has?
Kristen Luethje has such skills as Cross Functional Team Leadership, Medical Devices, Product Development, Design Control, Program Management, Quality System, R&D, Iso 13485, Fda, and Validation.