FRANK WINTERROTH

Campbell, CA ***** ad0kwe@r.postjobfree.com 650-***-**** linkedin.com/in/frank-winterroth

PROJECT MANAGER, RESEARCH AND DEVELOPMENT/SENIOR BIOMEDICAL ENGINEER/ SENIOR MEDICAL WRITER

Experienced biomedical engineer and project manager, specializing in biotechnology and clinical/technical writing and regulatory affairs – Phase I and Phase II. Extensive project management background within clinical and research areas (GCP/GLP and management), compliance with ICH guidelines, supervision of research projects, and medical writing, Strong publication record: journals, conferences, and textbook chapter. Experience includes working in hospital pharmacy. Reviewer for numerous biomedical engineering journals. Bilingual in Japanese. Other core competencies include:

Project Management: Quality Assurance and Regulatory Writing. Primary and contributing author on clinical evaluation reports/clinical study reports (CERs/CSRs), risk analyses, and periodic safety reports on medical devices and services (EU MDRs and Integrated Safety and Efficacy Standards: ISS/ISE), IRB protocol development and project execution; ISO 13485 compliance reports; SOP compliance and medical device reports preparations; Corrective and preventative action reports; IND reviews/reporting; Project management, including stage-gate project applications, coordinating projects, and executing change management principles toward R & D and information regarding medical devices and pharmaceuticals.

Medical Devices, Bio-Imaging, Biomechanics and Materials, Computer Skills. Medical Device Background Including: Ultrasound; Pulmonary Drug Delivery (both device designs emphasized human factors for safety and maximum operations); Cell Bioreactors; Microscopy: acoustic, light, and electron; MATLAB, Mimics/CAD, 3D Printing; Statistical analyses.

Tissue Engineering and Nanoscale Neurology, Biomarkers, Cell Biology and Chemistry Skills. Applied biomarkers to assess growth and development of axons in nanoscale neurology research (neuromuscular regeneration); Cell/tissue cultures; in vitro and in vivo models and assays; liquid scintillation assays; enzyme immunoassays, Western blots, PCR, HPLC, flow cytometry.

WORK EXPERIENCE

Fang Consulting, Roseville, MN

Medical Writer – Remote 07/2022 – 01/2023

Revised, edited, and reconstructed clinical evaluation reports (included Phase II trials), periodic safety update reports, and risk hazard analyses in accordance with US/EU MDR/MDD regulatory standards and ICH guidelines for hearing aids and patient gas tube assemblies. This includes post-clinical follow-up on biocompatibility and potential adverse effects.

Johnson & Johnson Medical, Irvine, CA. 06/2021 – 11/2021

Senior Medical Affairs Specialist – Remote

Authored and maintained clinical evaluation reports/clinical study reports (CERs/CSRs) and plans including Phase II clinical trials, post-market safety reports (PMSRs) for medical implants. Examined biocompatibility and adverse events for breast implants. Revised, edited, and reconstructed clinical evaluation reports (included Phase II trials), periodic safety update reports, and risk hazard analyses in accordance with US/EU MDR/MDD regulatory standards and ICH guidelines for hearing aids and patient gas tube assemblies. This includes post-clinical follow-up on biocompatibility and potential adverse effects.

ACM Laboratories, Rochester, NY 03/2021 – 05/2021

Medical Writer- Remote

Produced global laboratory documentation for sponsored clients to improve clinical efficacy with patients.

Private Biotech Company 01/2020 -08/2020

Senior Research Scientist/Medical Writer, Remote

Produced medical documentation (CERs); Reviewed, revised, and managed biotechnical materials (labels, product manuals); Collaborated with clinical clients, emphasizing human factors principles. Performed and supervised relevant scientific literature reviews. Implemented change management for clients to improve and streamline their medical device services.

Philips Medical Systems, Stanford, CA 10/2018 – 06/2019

Clinical Regional Scientist: Research and Development/Human Factors Engineering

Research and Development (Collaboration with Stanford). Collaborated with physicians, surgical techs, nurses, and other personnel during surgeries. Effectively utilized change management: developed, executed, and managed new clinical procedures and research programs (implementing greater human factors principles) in image-guided therapy and in pediatric interventional therapies. This improved patient care and safety/efficiency for healthcare personnel. Collaborated with Stanford University Medical Center to improve patient safety and efficacy on their image-guided therapy systems. Authored journal manuscript studying theoretical methods to better employ noninvasive imaging devices (CT and diagnostic ultrasound) for the improvement of diagnosing conditions of organs/tissues.

Novartis, San Carlos, CA 06/2016 – 12/2017

Scientist/Medical Writer, Technical Research and Development and Human Factors Principles

Wrote and reviewed clinical study protocols and CERs on the robustness and performance of inspiratory filters used in long-term respiratory drug delivery. Applied stage-gate project analyses, emphasis on product/service development, verification/validation, re-testing (as needed), and launch. Trained and managed lab personnel to conduct pulmonary drug-delivery studies, including safety and efficacy standards. Coordinated meeting to evaluate usability research methods on respiratory units, emphasizing human factors so that patients can manage self-care. Performed and directed safety and efficacy verification and validation studies on respiratory drugs and drug-delivery in late-stage clinical trials. Regularly presented key findings to the executive committee and collaborated with physicians and healthcare teams.

Elan Technologies, Ann Arbor, MI 10/2015 - Present

Bioscience Researcher / Medical Writer, Human Factors Studies (off site)

Managing the Bioengineering team on health improvement methods and programs within developing regions, both domestically and abroad. Designing and producing a patented smoking cessation system consisting of a customized in-house built cigarette simulator (produced using 3D printing methods) and Smart Phone app to wean smokers off tobacco use. Applied human factors engineering to the simulator to make it most applicable for the users.

Genentech, South San Francisco, CA 05/2015 – 09/2015

Project Manager Field Operations/Information Management

Trained and managed co-workers and assistants on IT issues including software usage and their applications and to perform online journal searches related to Phase I and Phase II trials for brand pharmaceuticals and biosimilars. Applied change management to improve understanding of brand name products and biosimilars: studied public proceedings of key opinion leaders (KOLs) related to brand name pharmaceuticals – including INDs, Safety and Efficacy Standards (ISS/ISE) - and successfully compiled them using Linguamatics I2E software. Wrote scientific reports and presentations detailing KOL’s discussions.

University of Michigan, Ann Arbor, MI 09/2005 – 04/2015

Research Fellow/Laboratory Manager/Medical Writer, Biomedical Engineering

Trained and managed research assistants, technicians, and graduate students in medical research studies: devices and pharmaceuticals. Authored multiple protocols and academic journal papers applying ultrasound to study engineered oral mucosal implants. Instituted GCP and GLP to ensure successful biocompatibility outcomes of tissue constructs for patient applications. Prepared and wrote institutional review board protocols and standard operating procedures in the use of high-frequency acoustic microscopy to examine cells and tissues. Collaborated with physicians, dentists, and other clinical staff on clinical trial studies. Extensive cell/molecular biology research includes utilizing biomarkers to assay the growth and development of neurites in nanoscale neurology studies. Analyzed non-linear elastic properties in natural and engineered skin and soft tissues using high-frequency ultrasound. Examined biocompatibility (inflammation and sensitivity) in permanent tissue constructs. Collaborated with oncology research to test properties of metastatic tumors to healthy tissues by examining their mechanical properties. Successfully designed, developed, and utilized a self-contained bioreactor.

ADDITIONAL RELEVANT EXPERIENCE: Philips-ADAC Laboratories: Complaints Investigator, Regulatory Affairs

EDUCATION

PhD, Biomedical Engineering, University of Michigan, Ann Arbor, MI

MS, Biomedical Engineering; Graduated with Distinction, California Polytechnic State University, San Luis Obispo, CA

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