DANIEL B. OSTROFF, B.S.
A dedicated, team spirited, and performance-driven engineering professional with over 6 years of Mechanical Engineering experience and 15+ years of experience in medical research. Seeking a challenging permanent position and an opportunity to grow with a dynamic, fast-paced organization while pushing limits of medical device technology.
Bachelor of Science: Biosystems Engineering / Biomedical Applications University of Arizona, Tucson, AZ
-Research and Design: Project/Quantification Planning, ISO & Safety Compliance, On- and Off-line Test Development, Statistical Analysis, Design & Validation, and New Product Introduction
-Production: Process Automation/Improvement, HMIs (Human-Machine Interfaces), Sensors (flow, pressure, temperature), Lean/Six Sigma, PPAP (Production Parts Approval Process), DFM/R/S/A (Design for Manufacturability, Reliability, Serviceability, and Assembly),
-Management: Excellent leadership, interpersonal, verbal, technical writing, and presentation skills.
Strong problem solving, time management experience in resolving technical/production issues
-Languages: English, Spanish (basic proficiency)
Xeridiem Medical Devices Tucson, AZ
Manufacturing Engineer - Special Projects Room March 2019 - Present
-Proficient in guiding product development to meet deadlines, budget, and customer specifications. Projects include:
●A device to treat atrial fibrillation through the coagulation of cardiac tissue (current product)
●The next generation of Afib treatment devices to expand customer product line (new product)
●Dual function Endotracheal Tube with a revolutionary body temperature regulation function (new product)
●A catheter with accessory kit for the use in Hospice care (current product)
-Adept at training company personnel and optimizing equipment, ensuring team efforts meet or exceed all goals
-Developed and lead Design Verification and Validation Activities, Master Validation Plans, Preventative Failure Mode Analysis, and Continuous Improvement (CAPA) plans
-Highly familiar ISO 13485:2012, Code of Federal Regulations (CFR) 21 Part 820, (QSR), 07 OCT 1996, Canadian Medical Device Regulation (CMDR), SOR98/282, and ISO 14971:2007 standards.
-Utilize PPAP and DFM for production improvement. Re-design equipment using SolidWorks to improve efficiency: Plan, execute, validate, maintain and improve instruments, equipment, components, and systems
Sigma Technologies International Tucson, AZ
Lead Mechanical Engineer – Capacitor Manufacturing 2014-March 2019
-Responsible for safe, efficient, and consistent deposition of metals and polymers through the maintenance and operation of complex automated systems
●Managed a small group of employees to meet or exceed production goals and developed detailed training documents/standard operating procedures for new employees
●Adopted and implemented 5S and 6 Sigma practices to maximize production efficiency
Roche – Ventana Medical Systems Oro Valley, AZ
Manufacturing Research Associate 2013-2014
-Manufactured reagents for BenchMark ULTRA diagnostic system and executed molecular assays including Bioburden, ELISA plate, and Tissue testing
The Solar Store, LLC. Tucson, AZ
Drafter/Solar Advisor/IT Consultant 2011-2013
-Used AutoCAD to draft schematics for Commercial and Residential projects. Additionally, assembled small PV systems
University of Arizona Medical Center, Dept. of Pediatrics Lung Injury Lab Tucson, AZ
Design and Marketing Strategist/Senior Laboratory Assistant, (P-T) 2002-2010
-Conducted experimental trials in Cancer (Leukemia) treatment, Acute Respiratory Distress Syndrome, and a NASA study exploring the Effects of Microgravity on Internal Organs
Sun N Wong SS, Nardi C, Ostroff D, Witten MI, Lantz, RC, Jan 2007. In Vitro Pro-Inflammatory Regulatory Role of Substance P in Alveolar Macrophages and Type II Pneumocytes after JP-8 Exposure. Journal of Immunotoxicology, 4:61-67.