Lauren Kraiter Email and Phone Number
• 15 years of experience as a dynamic team player in the medical device industry, with successful product management of complex medical products from concept to commercialization .• Proven track record in building and managing KOL relationships and advisory boards, complemented by primary market research with patients and field personnel. • Expert in uncovering unmet user needs and bridging diverse perspectives to define actionable engineering roadmap and product requirements to implement impactful solutions.• Extensive knowledge in medical device innovation, including market analysis, business case development, regulatory and reimbursement strategies, and intellectual property.• Known for effective communication and talent for structuring productive meetings with clinicians, engineers, and executives, particularly to drive decision-making under uncertainty.• Unique ability to blend abstract thinking and analytical skills to drive product strategy and development, with a strong motivation to make a positive impact on lives.
Biotronik
View- Website:
- biotronik.com
- Employees:
- 3647
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Director, Neuromodulation Upstream MarketingBiotronik Jul 2022 - PresentLake Oswego, Oregon, United States• Led all product management activities during an 8-year development cycle to define and develop the company’s first-ever neuromodulation product, culminating in FDA approval and successful launch.• Drove the creation and deployment of inaugural strategic plan for Biotronik’s new Neuro division by organizing and facilitating a year-long series of workshops with key stakeholders.• Established and managed physician advisory boards from scratch, serving as the primary liaison for two neurostimulation applications (pain and heart failure)• Directed product concept, customer requirements, and feature development through usability studies, workshops, interviews, and field observations with physicians, patients, and representatives.• Crafted and communicated the product vision, strategic roadmap, and market requirements, collaborating with engineering teams on technical specifications for complex implantable systems and digital health tools.• Contributed to intellectual property strategy with over 10 patents filed; received the company Innovation Award for a remote programming solution.• Trained education and commercial marketing teams and supported the creation of promotional materials for product launch.• Evaluated new market opportunities through research, regulatory pathway, reimbursement strategies, competitive analysis, and scientific reviews. -
Associate Director, Neuromodulation Upstream MarketingBiotronik May 2021 - Aug 2022Portland, Oregon Metropolitan Area -
Manager, Neuro Technical Product ManagementMicro Systems Engineering, Inc. Mar 2018 - Oct 2021Lake Oswego, Or
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Senior Technical Product ManagerMicro Systems Engineering, Inc. Jan 2016 - Mar 2018Lake Oswego, Or
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Senior Clinical And Applied Research EngineerMicro Systems Engineering Inc. Aug 2012 - Dec 2016Portland, Oregon Area• Drove start-up of pre-clinical & clinical studies for novel stimulation investigation: protocol generation, site identification & screening • Delivered technical support for pre-clinical studies, including training on implantation techniques, operating research systems, and collecting physiological data.• Acted as the main liaison with CROs for study planning, contracts, budgets, and data management.• Performed cardiac and neuro study data analysis including signal analysis & automated processing in Matlab & Excel; delivered reports and presentations of study results
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Bioengineering Innovation & Design Grad StudentJohns Hopkins University May 2011 - May 2012• Developed with team a nasal insert to facilitate drug delivery for chronic sinusitis treatment. Conducted project reviews with physician panels, FDA, engineering consultants, and legal firms. • Designed with team a low-cost fetal heart monitoring device for the developing world, including acoustic hardware, signal processing and programming, and form factors. • Identified and validated clinical needs through 300+ hours of clinical rotations at Johns Hopkins Hospital in electrophysiology, interventional radiology, general surgery, and cardiothoracic surgery.• Authored animal and clinical study protocols and achieved ACCU and IRB approval. • Performed pre-clinical testing, including self-devised bench testing, primate animal studies, and cadaver studies.• Traveled to Ethiopia for 3-week immersion to research clinical needs in low-resource environment. • Selected to present at Yale Global Health and Innovation, University of Minnesota Design of Medical Devices, and American Society of Mechanical Engineers Conferences. -
Technical Service AssociateBiotronik, Inc Aug 2007 - Feb 2010• Responded to inquiries from clinicians, field representatives, and patients to troubleshoot pacemaker/ICD programming and implantation, interpret ECG recordings, and describe technical information.• Completed training in pacemaker/ICD/CRT programming, testing, and implant technical support. • Authored user manuals, technical bulletins, and product training materials; presented new publication ideas.• Developed comprehensive new-hire training program objectives and exercises and led training sessions.• Led workshops for doctors, nurses, and field representatives on device programming and troubleshooting.• Communicated user feedback to engineering and marketing teams; filed complaints according to FDA QSR.
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Hospital Engineer VolunteerDuke University- Engineering World Health Jun 2006 - Aug 2006Completed one-month intensive training program in medical instrumentation and Spanish· Conducted inventory and staff interviews for needs assessment in Nicaraguan hospital· Utilized newly acquired knowledge to troubleshoot and repair hospital medical devices· Trained nurses and doctors to operate donated or repaired equipment and provided translated instructionsheets
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Systems Test Engineer Co-Op, Computed Tomography (Ct) Verification & ValidationPhilips Medical Systems Jan 2005 - Aug 2005· Executed clinical CT protocols and filed results in database to evaluate developing versions of software and hardware · Compiled and presented automated test data and equipment status reports at daily meetings with project managers, development engineers, clinical test site coordinators, and technicians · Co-authored comprehensive CT testing operations manual containing basic through technical reference information and testing protocols -
Cardiac Physiology Research AssistantThe Ohio State University May 2004 - Aug 2004· Performed ECG setup and lab animal exercise protocol to investigate canine arrhythmia · Assisted in surgeries for cardiac lead implantation and myocardial infarction production · Collected ECG and vagal tone data and analyzed with statistical software program
Lauren Kraiter Education Details
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Bioengineering Innovation And Design -
Biomedical Engineering -
Van Buren
Frequently Asked Questions about Lauren Kraiter
What company does Lauren Kraiter work for?
Lauren Kraiter works for Biotronik
What is Lauren Kraiter's role at the current company?
Lauren Kraiter's current role is Director @ BIOTRONIK Neuro | Upstream Marketing & Product Management.
What schools did Lauren Kraiter attend?
Lauren Kraiter attended The Johns Hopkins University, Case Western Reserve University, Van Buren.
Who are Lauren Kraiter's colleagues?
Lauren Kraiter's colleagues are Stefan Nagel, Elke Feils, Tino Hönemann, Soumen Mukherjee, Munten Stéphane, Augustine George, Vincenzo Bombaci.
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