Kristen Bean Email & Phone Number

Chicago, Illinois, United States

Leading and building a growing Applications Engineering organization within a fast growing start-up that develops wireless sensor technology and patient monitoring solutions for home and clinical care and clinical research.

Andover, Massachusetts, United States

Drove strategic planning for the Applications Engineering organization for Patient Monitoring business unit spanning full portfolio responsibility from legacy patient monitoring, accessories, and IT products to development of next generation products.Managed a budget of $10 million, with up to 36 full-time Draeger employees and 8 contractors (including Systems Engineers, Clinical Engineers, Risk Managers, Human Factors Engineers, and UI/Ux Designers). Spearheaded initiative to reorganize product development teams using scaled agile framework model, improved efficiencies by implementing iterative development processes, empowering systems engineering and clinical engineering to guide the development of integrated systems, completing 80% definition activities within 8 months. Led project and process improvement initiatives for validation and traceability activities in support of 4 critical 510(k) submissions related to Warning Letter activities which received clearance within 2 years allowing removal of US ship hold for monitoring product.

Andover, Massachusetts, United States

Andover, Massachusetts, United States

Managed and mentored a diverse team of 9-14 clinical engineers, comprising of clinical engineers, clinical specialists, human factors engineers, and UI designers.Generated and maintained workforce plans to meet business strategy and product roadmap. Reassessed team and recruited and retained highly skilled staff increasing team size by 50% to support growing portfolio and to expand core competencies for usability and clinical evaluations to meet the increasing regulatory demand.Effectively planned and managed EU MDR strategy for clinical evaluation deliverables for Patient Monitoring portfolio. Successfully met an aggressive 1.5-year timeline to release clinical evaluation documentation for 12 Class I and Class II products (over 250-part numbers). Managed hospital recruitment to support clinical testing. Expanded hospital partnerships by 50% in 2019/2020.

Andover, Massachusetts, United States

Led a team of 4-6 algorithm engineers in driving scientific development and innovation in physiologic parameters and smart alarms. Algorithm projects included arrhythmia enhancements, ECG detection enhancements, respiration, pace detection, and uni- and multi-variate alarm validation.Led algorithm development process improvement initiative after R&D reorganization to optimize, define, and standardize algorithm development and product integration. Led research project for an innovative pace detection and rejection algorithm, prototyped and patented algorithm after extensive field investigations of clinical complaints and data collection and analyses.

Andover, Massachusetts, United States

Systems engineering lead for our next generation patient monitor managing requirements management activities, including design input definition and traceability, system integration and clinical testing of the front-end acquisition subsystem. Created and managed the first system integration milestone for initial front-end build to verify performance of ECG algorithm. Created a common patient monitoring requirements structure in DOORs that improved traceability and allowed reuse and harmonization of requirements across monitoring products, including 8 particular standards that were translated into system requirements.

Andover, Massachusetts, United States

Led system and clinical engineering activities on cross-functional product development teams designing multi-parameter patient monitoring devices, including Infinity Explorer, Infinity Acute Care System, and M540 patient monitor. Responsible for requirements management, system integration, clinical evaluation documentation (MDD), product validation (usability, alpha/beta), and clinical studies.Lead Clinical Engineer for M540 patient monitor and served as Product Owner/Voice of the Clinician for four major releases, working with clinicians and OEMs to understand workflows and user needs for new feature/functionality, including Microstream, Nellcor Oximax, Masimo Rainbow technology, and numerous algorithm enhancements. Managed and conducted clinical investigations for new algorithms, including non-invasive blood pressure, to demonstrate performance of algorithm improvements in compliance with ISO 81060-2 and successfully obtained regulatory approval.

Member of research team evaluating silk scaffold as a biomaterial for bone regeneration. Worked as surgical assistant on small and large animal models, including anesthetic preparation/induction, post-operative care, and monitored/maintained research specimens. Managed data and documented results from various analyses (including radiographs, dual-energy x-ray absorptiometry (DEXA) diagnostics, and mechanical testing).