Director of Product Research & Development

• May 2023 - Present

Lead Quality Assurance Engineer

• Aug 2022 - Jan 2023

QA support to engineering, software, sustaining, and operations for all product development and manufacturing projects. Provide guidance on quality assurance requirements, documents, and the overall quality system. Develop, review, and approve quality/controlled documents. • Develop, review, and approve risk management activities (hazard analysis, failure modes and effect analysis (FMEA),risk benefit analysis, etc.) for hardware and software. • Lead quality engineer for an opto-acoustic (OA) imaging probe and phantom project. • Collaborate on the development of Early Feasibility Medical Device Clinical Study protocols and associated documents forIDE applications. • Assist in regulatory activities such as COFEPRIS registration, certificate to foreign government (CFG), and annualreporting for a Class III imaging system. • Complaint handling (investigation and reporting) for a Class III imaging system. • Review protocols, testreports, and records for adherence to standards and written protocols. Review and approve device history files (DHR) for manufactured products. Show less

Project Engineer - Product Development

• Nov 2018 - Jul 2022

Designed and developed biomedical implants in conformance with FDA, ISO, and AATB standards. Composed, reviewed, and executed process validations, R&D studies, batch records, and standard operating procedures. Project manager for all aspects of new projects to meet projected timeline milestones. • Developed and launched 5 new products in the past 3 years. • Designed CNC manufacturing processes for cervical and sacroiliac (SI) structural implants. Drafted and validated manufacturing Macro Gcode programs for CNC manufacturing of implants. • Developed and implemented manufacturing process revisions to increase efficiencies and reduce costs. • Collaborate with QA, QC, Operations, Manufacturing, and Distribution. departments for the launch of new processes/products. Conducted group trainings for new processes, products, and product release criteria and documentation. • Investigated non-conformances and product complaint reports. Determined product disposition for non-conformances and composed product complaint responses. • Collaborated with the sales team to determine project scope and design specifications for new products. Collaborated with the finance departments to develop COGS for new products and change in processes. •Compose and conduct process validations, sterilization validations, and shelf life validations for new products. Assisted the QA and QC departments with the development, interpretation of results, and reporting for cleaning validations and environmental monitoring of ISO classified cleanrooms. Show less

Biomedical Engineer - Product Development

• Jun 2018 - Nov 2018

Involved in a variety of R&D projects for the manufacturing and development of medical devices for drug delivery, collagen grafts, and nanoparticles for drug delivery purposes. • Collaborated directly with stakeholders to develop new products. • Synthesized liposomes, PLGA, magnetic, and upconverting (laser activated) nanoparticles for drug delivery. • Executed the mechanical testing of materials, measure material contact angles, cell culture, and composed technical analytical procedures and summary reports. • Executed GLP projects, maintained GLP requirements and documentation for QA purposes. Show less

Quality Control & Product Development Engineer

• Apr 2017 - May 2018

Handled a broad scope of responsibilities, troubleshoot technical problems,composed SOP’s, trained full time personnel, maintained clinical analyzers, and managed research and product development projects. • Collaborated with stakeholders to implement manufacturing processes. • Worked on the fully life cycle of product development, requirement gathering, implementation, and quality control. • Project Manager for the Test Method Validation of an Enzyme Acceptor protein for a Fentanyl Urine Enzyme Immunoassay; received FDA approval. Developed new products and standard operating procedures. • Performed maintenance,quality control, and calibration procedures for clinical chemistry, immunoassay, and coagulation analyzers that performed up to 300+ tests a day. • Performed multianalyte Value Assignments for manufactured In vitro diagnostic (IVD) controls. • Executed Final QC procedures for manufactured products prior to shipment. • Performed Column and Bulk Affinity chromatography/purification for ASO antibodies. Show less

Undergraduate Research Assistant

• Aug 2016 - May 2017

• Performed rupture risk analysis of patient-specific Abdominal Aortic Aneurysms (AAA). • Performed segmentation of AAA’s from patient specific contrast enhanced computed tomography (CT) images with the use of MATLAB, generated meshes for computational analysis and 3D modeling of AAAs, and calculated geometric indicies of AAAs. • Performed Finite Element Analysis simulations of AAAs through ADINA software to quantify geometric parameters. • Performed post processing of FEA simulation for biomechanical parameters through Ensight software. Show less