Board Member

• Jan 2023 - Present

Director of Operations and Medical Affairs

• Jan 2023 - Present

Partner to establish a network of orthopedic and neurologically trained spine surgeons and act as a liaison of scientific and clinical communication in support of military special operation force (SOF) advocacy, treatment, and clinical education for back pain and spine injuries. Establish HIPPA-compliant patient provider portal/remote clinical triage of active and retired SOF community members, resulting in successful virtual round table case reviews performed by a network of ortho/neuro spine surgeons, allowing SOF operators unbiased care recommendations focused on anatomy conservation and motion preservation techniques for treatment of spinal pathologies. Organize virtual and in-person clinical education and community outreach events related to back pain, spinal pathologies, new technology, and treatment options, driving program adoption and partnerships within the U.S. military branches. Show less

Consultant

• May 2016 - Present

Specialized in establishing scalable quality management systems for early-stage to mid-sized medical device companies compliant with FDA 21 CFR 820, ISO 13485:2016, MDD, and EU MDR, as well as combination devices compliant with 21 CFR 211/210. Oriel STAT A MATRIX, Principal Consultant, Quality, Clinical and Regulatory Affairs. Medical Engineering Consultants, MEC, Lead Auditor, contracted to perform internal process audits on behalf of acquired company in support of transitional merger and acquisition activities. Contracted to assess conformance of sub-tier suppliers for Institutional Review Board services compliant with FDA 21 CFR Part 50 and 56, and 45 CFR Part 46, OHRP, FDA, EPA, ICH GCP, Canadian Food and Drug Regulations, Tri-Council Policy Statement 2 and CIOMS, Belmont Report, Nuremberg Code, Declaration of Helsinki, as well as supplier compliance to Good Laboratory Practices (GLP), 21 CFR Part 58 for class III combination product. Show less

Director of Clinical Research

• Jul 2021 - May 2023

Direct all aspects of department operations, including project oversight, fiscal management, contract negotiation, resource management, personnel training, site recruitment, data protection, and conversion of clinical claims to marketing materials. Lead international and domestic clinical investigations supporting ongoing post-market surveillance, clinical follow-up, and clinical evaluation in compliance with international and domestic regulatory requirements, including EU MDR and ISO 14155. Assess product benefit-risk profile utilizing key performance indicators as inputs to mandatory reporting documents to be submitted to Notified Body i.e., SSCP, PSUR Collaborate with cross-functional team to generate technical documentation, including Clinical Evaluation Reports (CER), and State of the Art Clinical literature reviews for EU MDR certification. Optimize clinical strategy for expansion of product registration to drive market adoption within international and domestic markets resulting in increased revenue for the company. Spearheaded multi-center prospective, retrospective, and investigational research studies with an emphasis on data protection for human subjects. Facilitate partnerships with private and academic healthcare networks, as well as KOL's, to determine the relevance and impact of clinical focus and drive further product innovation. Plan and execute data-centric clinical research engagements for industry conferences, data seminars, and peer-reviewed publications to advance the standard of patient care thru the adoption of access to enabling technologies. Collaborate with key opinion leaders, clinical investigators, and professional societies to support clinical studies and generate clinical evidence to support product claims. Show less

Director Of Quality & Clinical Research

• Jun 2017 - Jul 2021

Management Representative of Integrity Implants appointed by CEO, to act as executive representative and liaison for regulatory bodies, including the Food and Drug Administration, Notified Body, and other applicable governing agencies. Established Quality Management Systems for fully operational systems compliant with FDA’s 21 CFR 820, ISO 13485:2016, ISO 14971:2019, MDD & EU MDR requirements to allow development and international distribution of spinal implants and instrumentation under EC certification issued by notified body TUV SUD. Established and managed Quality Management Systems in all areas of operation, including Supply Chain Quality, NCR, CAPA, Complaints, MDRs, Recalls, Field Withdrawal, Supplier Controls, and product life cycle management. Responsible for timely reportability assessments to regulatory authorities for field events, as well as timely execution and closure of high-risk field actions. Established design control process for new product development, including design history files, statistical techniques, verification and & validation requirements, biocompatibility assessments, and product lifecycle testing in accordance with ASTM/AAMI/ANSI standards. Successfully implemented in-house product realization of spinal implants and instrumentation, including equipment qualifications (IQ/OQ) and process validations (PQ), in partnership with QMS updates for inclusion within the company's ISO 13485:2016, MDD, and EC Certification. Established and validated electronic product life cycle management and document control software utilized for control of records, DHF’s, CAPA’s, Complaints, and other QMS processes. Developed team of top-performing engineers and specialists within cross-functional roles to foster an environment of inclusion and excellence within the organization. Show less

R&D Engineer

• Jan 2015 - Jun 2017

Designed and developed Class I and Class II spinal implants and instrumentation from concept generation through commercialization for lumbar and cervical fixation systems, including deformities, PLIF, TLIF, Open, Mini-Open and Minimally Invasive procedures, as well as posterior sacroiliac joint (SI) fusion.Lead verification and validation testing, biomaterial assessments, transit testing, cleaning, and sterilization assesments, dimensional tolerance analysis, equipment tooling specifications, inspection requirements, labeling, and risk assessments in line with ISO 14971, including hazard analysis, FMEA’s, risk management plans and risk management reportsUtilized advanced manufacturing techniques for the commercialization of 3D-printed porous cervical and lumbar interbody fusion devices that promote osteointegration for spinal fusion. Spearheaded Unique Device Identification (UDI) activities including the establishment of labeler/GUDID accounts, UDI implementation strategy for orthopedics, and data submission.Performed timely CAPA and complaint investigations, including root cause determination and corrective actions Show less

Quality Engineer

• May 2013 - Jan 2015

Supplier Management: supplier qualification and surveillance audits, process validation CAPA Coordinator: Managed CAPA process, including trending and statistical analysis, root cause determination, corrective actions, and verification of effectivenessMaterial Control: Managed nonconforming materials process, including supplier relations, investigations, risk assessment, and disposition of nonconforming product; Established inspection process and equipment calibration requirements; Released product for use; Maintained Device Master Records (DMR) Complaints: Investigate complaints and field feedback reports, identify root causes, asses failure trends, and identify and execute corrective actions Collaborate with cross-functional team to prepare regulatory filings, including 510K submissions and letters to file. Show less

Biomechanic's Research Assistant

• Feb 2012 - Jan 2014

NIH certified to work with human subjects in research (#: 955025) Collaborated with clinicians at NCH Brookdale Center for Healthy Aging and Rehabilitation along with interdisciplinary university faculty to conduct biomechanics research involving stroke and Parkinson’s disease using equipment and software specific to modeling human performance (Visual3D, Qualysis) Plan and execute integrated research examining the relationship between proximal neuromuscular activation of the hip and the control over distal segments of the lower extremity using equipment and software specific to modeling human performance (Visual3D, Qualysis) and EMG monitoring (Noraxon) Develop computational processing code for joint kinematics, force transfers, and EMG processing (RMS/low pass & band pass filtering) Show less

Aqua Culture / Culture Collection

• May 2011 - Feb 2012

Designed and developed experimental photobioreactor systems, including sterilization, inoculation, gas transfer, fluid dynamics, material strength, and durability testing under simulated loading conditions Developed computational modeling systems to predict cyanobacteria culture growth (ethanol production) under varying photobioreactor conditions for scale-up and commercialization of bio-fuel facility. Analyzed genetically modified cyanobacteria culture behavior in closed system photobioreactors for biomass accumulation, sterility, and ethanol production using fluorescence and absorbance analysis, light density, dry weight filtration, polarization and depolarization currents (PDC), CC plates, pH measurements, and mass spectroscopy Prepared specialized media mixtures to promote culture health for genetically modified cyanobacteria Designed and constructed gas and liquid transport lines to maintain culture health and expand infrastructure for scale up activities for commercial bio-fuel facility Show less