Alexei Smirnov

Broomfield, CO 845-***-**** acxdmm@r.postjobfree.com

Experienced biomedical engineer trained in the design, development, and production of complex devices. Skilled in design, production readiness and detailed engineering documentation. Highly capable of working under minimal supervision, or collaboratively with multi-functional teams. Possess excellent interpersonal and communication skills.

CORE COMPETENCIES

Biomedical Engineering Manufacturing Engineering Mechanical Engineering Medical Devices Prototyping

ASME Y14.5 CAD Product Engineering SolidWorks Design for Manufacturing Design for Assembly

Quality Control Testing V&V Product Support Teamwork Communication UL, FDA, CE compliance

PROFESSIONAL EXPERIENCE

Retro-LEDs, Broomfield, CO - Precision Dental Lighting 02.2015-06.2016

Mechanical/Manufacturing Engineer

Designed and developed an LED dental light from concept to production, including human factor evaluation

Designed optical components and injection molded parts

Conducted thermal and optical testing, and ensured the manufacturability of the design (DFM,DFA)

Established entire assembly process and documentation for manufacturing

Designed, built and tested all manufacturing fixtures for several product lines

MELA Sciences, Inc., Irvington, NY – Electro Optical System for Melanoma Detection. 06.2008-09.2014

Product Engineer II (2013-2014)

Project leader for new product design, liaised between R&D, Marketing, Clinical, and QA departments

Supervised V&V, and created QA/QC documentation in accordance with UL, FDA and ISO 13485:2003 guidelines

Decreased the cost of the imaging system by 60%, with significant reduction to device size

Created prototypes and majority of the engineering drawings used for production of parts, assemblies, and mechanisms using CAD (SolidWorks)

Developed test protocols, assembly floor instructions, product manuals, and support procedures

Managed rapid prototyping, machining, and testing of new products aimed for skin cancer detection

Senior Business Support Manager (2013)

Upheld close contact with more than 20 customers, ranging from major hospitals to small private

practices in several metropolitan areas New York, Cleveland, DC, Chicago, and Boston.

Provided training and mentorship to other Business Support Managers across the United States

Created strategies to drive utilization, successfully saving accounts and increasing patient demand

Business Support Manager (2012-2013)

Conducted clinical training for dermatologists across the United States regarding use of MelaFind

Helped customers to integrate MelaFind, and performed installations throughout the United States

Represented MelaFind at national conferences, and on several major segments on television

Product Engineer (2008-2012)

Awarded for fostering cooperation between departments

Supporting the design and development of an electro-optical medical device which aids dermatologists with early detection of melanoma

Designed and produced plastic, sheet metal, machined parts and mechanisms using CAD (SolidWorks)

Worked in conjunction with electrical engineers to attain 60601-1, UL and EU approvals for MelaFind

Collaborated with Quality Assurance and Marketing departments to ensure readiness for product launch

AWARDS AND ACCOMPLISHMENTS

Awarded for fostering cooperation between departments, by supporting the design and development of an electro-optical medical device which aids dermatologists with early detection of melanoma

Was quoted and referenced in a book “Care Quotient”, written about successful business leadership strategies, achieved through effective human interactions (by Dr. Joseph Gulfo, MD, MBA).

EDUCATION

Bachelor of Science, Biomedical Engineering

Stony Brook University College of Engineering and Applied Sciences Stony Brook, NY 2008

NCAA Division I Swimmer

Skilled in Scuba Diving, Alpine Sports, Skydiving, and Photography

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