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Engineer Quality

Jupiter, FL
March 26, 2019

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Mircea Paraschiv

631-***-**** PROFILE: Highly skilled technical specialist in electromechanical medical instrument research and development, manufacturing, and commercialization. Wide clinical portfolio including advanced animal, human, and cadaver studies. Expertise in all phases of product development including design control process, compliant with FDA GMP and ISO requirements, protocol creation, execution of testing, and completion of verification and validation reports. Areas of expertise include identifying and analyzing new technical concepts and devices useful to the medical field driving the design and development process for medical devices; establishing and achieving clinical research goals; and participating in collaborative efforts to facilitate market introduction of products. Demonstrated and consistent ability to interface with physicians, sales as well as cross-functional internal team including marketing professionals, quality, regulatory and production personnel, to realize the full potential and application of technology with the goal of delivering maximum results.

TECHNICAL SKILLS: ISO 9001, QMS (ISO 13485), FDA 21 CFR Part 820, ISO 14971 (Risk Management), IEC 60601-1, 3rd ed, ECN, ECO, GMPs, Cleaning and Sterilization, Biocompatibility, Disposables, Packaging and over 200 hours of operating room experience including extensive time in sterile field. Hands-on manufacture of tooling, test fixtures, prototypes, high-power, piezoelectric transducers at 20-55 KHz as well as low-power, robotically- guided, 2 and 4MHz single- and dual- focus imaging / therapy HIFU transducer development and manufacturing. EDUCATION: B.S – Computer Science/Information Technology, Farmingdale University Concentrations in informatics, database optimization and data analytics PATENTS:

Hook Shaped Ultrasonic Cutting Blade, US20080009848

Ultrasonic Wound Treatment Probe, US D664, 326 S PROFESSIONAL EXPERIENCE:

Misonix Inc., Farmingdale, NY 1998 – October 2018

Sr. Product Specialist/Product Development Engineer 2010 - October 2018 Product Description: Wound Care Ultrasonic System Instrument specifically designed for atraumatic tissue debridement, providing surgeons a safe and effective means of surgical soft and hard tissue management, as well as effective cleansing and removal of devitalized tissue while sparing viable tissue. Responsibilities:

Product development from design to product release.

Planning and schedule activities for new design and sustaining projects.

Develop documentation design input, test protocols and procedures according to applicable international medical device standards.

Design test prototypes of ultrasonic probes, including hands-on fabrication of ultrasonic transducers and product model layouts.

Approve design verification/validation activities including mechanical testing, tolerance analyses, and design rationales.

Coordinate activities and testing required for completion of verification/validation protocol, testing, and author reports according to written technical justifications.

Provide guidance: QA, Risk management, ISO audits, CAPA, PMS, NCMR, life cycle and product complaints.

Provided product presentations, demos, and training for physicians and internal stakeholders. Sr. Product Specialist/Senior Clinical Trail Specialist 2006-2010 Product Description: Robotically-guided ultrasonic surgical instrument, specifically designed to laparoscopically ablate renal tumors with minimally invasive ultrasonic energy with High Intensity Focused Ultrasound (HIFU) Responsibilities:

Oversee and participate in clinical research on human trials in three major European Universities (Oxford, Vienna and Torino, Italy).

Worked closely with marketing and overseas consultants.

Direct interaction with physicians and pathologists to evaluate each patient case, to ensure compliance with the research plan and protocol criteria.

Responsible for equipment installation and troubleshooting, software deployment, and operating room preparation.

Scrub-in to sterile field to assist surgeon with proper insertion, placement, and execution of therapy on target organ using sterile laparoscopic probe.

Additional responsibilities include: generation conceptual design, creation product model layouts, construction and iteration of prototypes, development of technical justifications and estimated project costs and risks, and collection and analysis of clinical data,

Fabricated HIFU prototypes transducers by hand and developed test protocols and procedures compliant with design control standards.

Sr. Product Specialist/Manufacture Engineer 2005-2006 Product Description: Innovative, robotically-guided ultrasonic surgical instrument designed for minimally invasive treatment for prostate cancer with High Intensity Focused Ultrasound (HIFU)Responsible for manufacture and final QA.

Engineer Aid 2002-2005

Responsibilities: Oversee three supporting products. Develop and organize technical training for production, quality, sales and marketing departments.

Ultrasonic surgical instrument, specifically designed to laparoscopically cut and coagulation for use within GI modalities. Responsibility: Evaluate and approve purchase of Titanium 6Al-4V ingots totaling $4M annually, used in the manufacture of disposable probes.

Ultrasonic Soft Tissue Aspirator, specifically designed for low-trauma liposuction using the principle of cavitation. Responsibility: Assessment of production data for monitoring and trending, sustaining support, and execution of engineering changes throughout the product life cycle.

Ultrasonic Cell Disrupter, specifically designed for ultrasonic cell disruption, and emulsification for laboratory and scientific use. Responsible for manufacturing and assembly oversight, troubleshooting, testing and final QA. Sr. R&D Technician 2000-2002

R&D Technician 1999-2000

Technician 1998-1999

Language Skills: English, Romanian, Spanish, Italian

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