- Lead and mentor technical specialists / clinical experts in the Active Devices team.- Proactively facilitate / streamline work in BSI’s notified body, and leading through massive growth and change.- Panel decision maker for the technical review committee to approve MDD, MDR and UKCA certificate 200+ reviews completed. Also a competence verifier, reviewing & approving the credentialing of scheme managers.- Ongoing investment in training new hires and colleagues inside of BSI to get them competent and productive as quickly as possible to meet BSI’s commercial and strategic needs. Colleagues I have recruited, hired and trained are rapidly productive and include two of BSI’s current top 4 earners and my department’s training lead. Building of templates, slides and other resources for our trainees. Collaboration with the training department to improve the new hire experience and develop content. Presenter for 30+ formal trainings on topics such as certificate renewals, ISO 13485, defibrillators, radiation therapy, defibrillators, MRI, risk management, technical auditing, etc.- Strengthen company though improving inter- and intra-team bonds. Organized 2 cross-functional local trainings to build stronger local support associations and facilitate better understanding and support of our unique roles in the BSI community, and to review our team's first two MDR technical files as a group to align interpretations and forge policy. I have cultivated a network of friendships on each team, which has facilitated inter-team collaboration. Active member of numerous working groups- 58 codes spanning a wide range of devices and roles inside of BSI- Excellent customer service to guide clients through the certification application and maintenance processes and acting as the client’s advocate inside of BSI through preparation of complete certificate decision files. Received multiple commendations from both clients and management, with clients specifically requesting me by name.

- Responsible for leading the technical aspects of design and development of new medical device/equipment products. Gathered clinical / VOC feedback. Facilitated communication between team members on large teams. Support and gap-fill as needed on strategic R&D projects.- Managed a program to expand indications for use for an oncology product including a new 510(k), animal studies, test method development, planning, and documentation.- Managed redesign of oncology product lines: Managed redesign efforts and performed GUI design for RF, microwave (Solero), and irreversible electroporation (Nanoknife) tumor ablation technologies into modular units with consistent user interfaces, and updated for 60601-1, REACH, and RoHS II.- Trained executive management, quality, and engineering personnel and lead seminars in use of risk-based tools, regulatory standards, Lean Six Sigma, clinical practice, sterilization, design controls, and relevant current/upcoming regulatory standards, usability engineering - Co-managed initial acquisition integration of microwave ablation system - Sustaining activities for laser venous ablation (Venacure) product line for RoHS II, 60601-1

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Responsible for ensuring medical device assemblies are fully validated, compliant with applicable regulatory and customer requirements. Developed new regulatory SOPs and new document / form templates.

Identified, initiated, and drove numerous product realization projects involving medical product design and ongoing support for products such as defibrillation electrodes, minimally invasive ECOMM endotracheal tube cardiac output monitoring device, and laparoscopic reflectance pulse oximetry, among others. Engaged in planning, design documentation generation, R&D, process qualification and risk management. Participated in marketing, manufacturing and procurement. Worked and coordinated with subcontract manufacturers and consulting services; developed manufacturing processes and products to grow the business by rounding out product portfolios such as ECG electrodes, disposable leadwires and multiparameter monitors. Managed department laboratory, designed laboratory test set-ups and acquired required electrical equipment- Managed the division’s IEC 60601-1 3rd edition compliance program and 3 technical staff members. Generated risk documentation, modified product labeling and performed testing to support compliance within a six-month period more than $120,000K under budget and supporting $7.5 million in international business- Released a successful new product in an acquisition-based company with no support structure for R&D; developed design documentation that was thoroughly audited by TÜV SÜD with zero non-conformities- Oversaw regulatory compliance initiatives, including Technical File and Design History File remediation projects- Consistently received exemplary performance reviews for contributions above and beyond expectations in assisting internal / external customers and knowledge sharing- Spearheaded the human subject volunteer test program, with a commitment to the safety and education of human test subjects- Built / developed an extensive network of product and service suppliers- Participated in Kaizen events and other lean activities

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Prepared lesson plans and taught English to 18 youths aged 2 to 7 years through a Montessori curriculum of hands-on activities. Performed needs assessments to determine student strengths and weaknesses. Served as a resource for students.

Conducted virus isolation, cell culture, and various other tests to support avian influenza research. Followed established lab protocol for specimen preparation for analysis and preservation of specimens. Performed clinical laboratory tests/examinations as requested by medical staff for use in clinical diagnosis and other authorized purposes.- Volunteered and led project to write and update standard operating procedures for all common lab tests, which greatly streamlined testing times and reduced errors and variances.- Spearheaded a workshop on MRI artifact reduction and improved pulse sequence design for the radiologists to improve image quality and patient risk through better understanding of the MRI technology.- Led a technician workshop on digital x-ray technology to provide deeper understanding of the new x-ray technology in the promotion of a seamless transition to the new digital x-ray medium and optimized work flows.

Developed time-saving bulk processing machine vision and segmentation software for confocal microscopy image analysis supporting ovarian cancer research.

Acquired practical hospital and human subject research protocol experience. Designed and wrote user-friendly signal processing programs to format, statistically analyze, and yield publication quality graphs for the raw data output from medical equipment gathering respiratory and other biological data for two human anesthesiology experiments.- Received employment contract extension from six months to two years to update several additional programs due to ease of use, batch processing capabilities, and functionality of the originally written program.

Provided empathetic care to patients and energetic customer service to clients. Took X-rays, gave vaccines / examinations, drew blood, prepared animals for surgery, and performed laboratory analyses of blood and urine. Assisted with anesthesia, surgery, dentistry, laboratory testing, and client education. Conducted patient assessments and communicated with physicians and other hospital personnel to ensure optimal provision of patient care.

Provided empathetic care to patients and energetic customer service to clients. Took X-rays, gave vaccines / examinations, drew blood, prepared animals for surgery, and performed laboratory analyses of blood and urine. Assisted with anesthesia, surgery, dentistry, laboratory testing, and client education. Conducted patient assessments and communicated with physicians and other hospital personnel to ensure optimal provision of patient care.