Senior Project Document Control

TOM CZEPOWICZ

***.*********@*****.***

phone contact: +48-798-***-***

Areas of expertise:

Medical Devices and Video Imaging, Precision Mechanisms and Instrumentation, Vibration, Structural/Dynamics, Thermal, Acoustic, and Kinematics. EMI/EMC containment. Radiation physics, and X-Ray / accelerator shielding. Control Systems and System Design. Statistical Process Control: Taguchi and ANOVA methods. FMEA. ASME Y14.5M GDT standards. 3D CAD design and Document Control. Prototyping: CNC multi-axis, 3D printing, metals, plastics, composites. Lab vibration and Instron testing. UL, RoHS, FCC part 18 ISM, part 15, ISO: 9001, 16949, 13485, 60601-1, and 20CFR820 medical devices.

Project Management: JIRA, TRELLO, Basecamp, Liquid Planner, PERT, Logframes, Risk Impact and Influence Mapping. Cross Cultural Team Management, Effective Negotiations. Relevant Experience Summary:

GENER8, Sunnyvale, CA . (6/18 - present)

Consultant on several biomedical and medical diagnostics projects. Instrumentation, vision systems, mechanisms, thermal management, kinematic motion, rapid prototyping, conceptual designs, client presentations and extensive lab prototyping and testing.

Avegant, Belmont, CA. (4/17 – 6/18)

Consulting and PM role in development of experimental Light Field mixed reality platform Video/Audio Headset

(https://www.avegant.com/video-headset), experimental multi lens array system for retinal holographic display with adjustable opto-mechanical parameters.

Microsoft, Mountain View, CA. (9/16 – 3/17)

Consulting and PM role in design and manufacturing of second generation of Hololens Display architecture and imaging. (https://www.microsoft.com/en-us/hololens/hardware) Prototype manufacturing, documentation, test fixtures and procedures. Gate reviews, engineering risk management, implementation of characterization tools and prototyping test methods across EE, ME, SW, and Opto-Mech groups between multiple geographic locations. LYTRO, Inc, S unnyvale, CA. (5/15 – 4/16, acquired by Google in 2018) Senior Project role in Virtual Reality and Augmented Reality technologies. Light Field Cinematographic camera design. Lytro scientific camera design. Internal educational seminars on camera systems. Cinematography clients and marketing liaison. Several patent applications for innovative solutions in Light Field technology. GoPro, San Mateo, CA. (11/12 – 3/15)

Senior Project role in development of Integrated Sensor Lens Assembly, thermal management technologies for H3+ and H4cameras. Created and managed offsite Advanced Camera Architecture Laboratory. Worked with Asian CM's coordinating high volume mfg. exceeding 850k units/month. Multiple patents for Integrated Sensor Lens systems. Consulting with NASA AMES research center designed “Lunar Plants” 3D system for monitoring plant growth and phototropism in space and Moon environment.

Accuray, Sunnyvale, CA. (1/11 – 6/12)

Senior position in design and development of “CYBERKNIFE” M10 treatment system. Radiation Physics tools, laser alignment systems design, X-ray shielding, accelerator validation and testing. Managed resources in China and US to implement FDA Class 3 device. Gate reviews, FDA process, risk, and Process Verifications and Validations. Lumenis Inc., Santa Clara, CA, and Haifa, Israel ( 3/09 – 5/10) Sr. Consulting PM role in the development and US market introduction of ERCP (endoscopic retrograde cholangiopancreatography) device with expandable laser tools and procedure options. Created US - Israeli - UK - German team to finalize design, V&V's, and US market implementation. Responsible for overseeing relationships with outside vendors and consultants, operations and manufacturing outsourcing. Manufacturing Process, Tooling, DVT’s, Mfg. Pilot, artwork design, ECO's, budgets and implementation deadlines, team coordination and PM functions. FDA approval process.

B C Tech, Inc., Santa Cruz, CA. (3/08 – 3/09)

Project Management role in optics and vision system based Medical Devices. Individual senior level engineering leadership. Business Development, client design presentations and proposals. Rapid prototyping, tight deadlines, precision budgets, extensive client contact, travel and reviews. Projects range: Steerable Catheters and Endoscopic Devices, Minimally Invasive Surgical Tools, Neuro Stimulators, and Blood Chilling systems. Manged team of 7 engineers, weekly resource allocations, budget and client reviews. Completed major medical projects on time and on budget. Active in UL, FCC, FDA agency approvals processes. Carpal Tunnel Minimally Invasive Tool project resulted in a major multi million acquisition for the client. NeoGuide Systems, Inc., Los Gatos, CA, ( startup, acquired by Intuitive Surgical ) 6/07 – 3/08. Principal and PM role in design and development of Endoscopic Surgical Device for cancer research and diagnostics. Robotically actuated endoscopic diagnostic and surgical section with camera, air, water and fiber optic light delivery system. Supervised Validation and Verification process, n 21 CFR 820, ISO 60601and FDA regulated Quality and Design Development System.

Avantis Medical, Inc., Sunnyvale, C A, (startup, acquired by private investors) 8/06 – 6/07. Principal role in management, design and development of Endoscopic 3D Camera Device for cancer research and diagnostics. Design of 2.8 mm catheter with camera tip, light delivery, cooling system, pilot manufacturing tooling. Managed and facilitated Validation and Verification processes, clinical studies with Stanford and Cleveland Clinic, under 21 CFR 820, ISO 60601and FDA regulated Quality and Design Development System. Other projects and experience:

KLA -Tencor, Milpitas, CA

Project and design function in system transfers to Intel, Sony, TSMC Taiwan. Consulting role in 300mm wafer optical inspection tools, manufacturing and design. Diagnostic and quality improvements using Taguchi methods in robotic optical wafer placement accuracy, reaching improvements by 33% using statistical experimental methods. Tyco Electronics, Sunnyvale, CA

Consulting and permanent role in design of automotive specialty materials and sensing equipment. Worked with Audi, VW, BMW, and Mercedes OEM teams to implement noise reduction materials in body frames and proprietary electronics capacitive sensing for Airbag Deployment Control System. Schedule and technical management of experiments with injection molding vendors, technical issues resolution with clients. Plantronics Inc, CA/ PLAMEX Mexico

Product and Project Management, development and manufacturing process in Telecom headset arena. Saved $12M in cost reductions for the company in parts and process optimizations. Implemented new production and packaging lines in Plamex Mexico within 6 months reaching 600k/month volume. Individual engineering contributor, Patent for User Adjustable Acoustic Headset.

Education

B.S.M.E. Cleveland State University, ME, Controls and Systems Engineering, Psychology U-Mass., Lowell, - Plastics Engineering

Univ. of Michigan, Ann Arbor, - FEA Engineering ANSYS, NASTRAN. Univ. of Wisconsin, - Executive MBA, PM.

Non thesis Ph.D, classical physics, Krakow, Poland Software

CAD: Solid Works, Creo Pro/Engineer, Analytics: Mathcad, MATLAB, Labview, Minitab. Scientific: ANSYS, NASTRAN, MoldFlow, Flotherm, Icepack, Fluent, Fastflo, Zemax, CFDesign. Personal Private pilot ASEL rated, ASA sailor, amateur telescope builder, photography, active volunteer in Polish Educational Foundation promoting Polish language and cultural heritage abroad, US citizen. Willing to relocate. Recent Patents

Light Guided Image Plane Tiled Arrays With Dense Fiber Optic Bundles For Light-Field and High Resolution Image Acquisition: 201********, Two Piece Dual Layer Transaction Device: US20200394370A1 Integrated image sensor and lens assembly : 10122902, 9609195, 201********, 201********, 201********. Headset with user adjustable frequency response: 5729605.

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