John Majewski Email & Phone Number

California, United States

Foster City, CA, US

Foster City, CA, US

Tel-Aviv, IL

• Lead design engineer for next generation inhaler technology for the treatment respiratory disease
• Execute design and development within cGMP regulated environment (21 CFR Part 4 & ISO13485)
• Main contributor for combination drug-device documentation per 21 CFR 820 Design Controls
• Rapid prototyping (CNC/3D printing), test method development/validation, and root case analysis
• Working extensively with global team and multiple CDO/CRO’s to complete device milestones/KPI’s
• Completed 3-month feasibility project from concept generation through prototypes and formative study

San Diego, California, US

• Technical expert on polymer and biomaterial membrane coating process for diabetic glucose sensors
• Creating and executing test protocols for factory-calibrated sensors in collaboration with Verily
• Designing assembly fixtures and equipment in SolidWorks for new product development
• Implementing Lean principles and maintaining PFMEA to reduce manufacturing and product risks
• Developing a vision system and test methods for mechanical testing of micro-needles
• Managing suppliers and contractors for R&D and commercial, with emphasis on sensor technology

San Diego, California, US

• Managed 28 operator team with effective communication skills as technical lead
• Technical expert on next generation glucose sensor manufacturing process in R&D pilot plant
• Implemented process controls to increase sensor yield from 80% to 97% over 2 months
• Created full process documentation (SOP, MPI, TP, LHR) for R&D products through pre-commercial

Charlottesville, VA, US

Advised senior capstone students at the University of Virginia on their design project in conjunction with LifeNet Health.

San Diego, CA, US

• Designed custom plastic enclosures for a wireless diagnostic medical device
• Modeled parts and assemblies to meet industrial engineering design specifications
• Used 3D printing techniques to produce prototypes for CES 2014 and investor presentations

As an intern, I am continuing my Capstone Design project through LifeNet Health. I am designing a new medical device to be used with LifeNet Health's orthopedic spinal fusion implants. The end goal is to create a full medical-grade prototype to be used by LifeNet Health's surgeons. My responsibilities include:-3D modeling-manufacturing techniques-rapid.

For my final Capstone Design project, I worked in conjunction with LifeNet Health, an organ and tissue bank located in Virginia Beach, VA. I working collaboratively in a team to design and produce a medical device to be used with LifeNet Health's orthopedic spinal fusion implants. Throughout the project, some responsibilities included: -networking with.

Charlottesville, VA, US

My lab responsibilities include genomic DNA purification, polymerase chain reaction assays, and gel electrophoresis.

I assisted in measuring residencies and construction sites with the architects. I utilized AutoCAD to create, alter, and finalize drawings for client submission, as well as prepared permit and zoning reviews.

Masters Of Advanced Study, Medical Device Engineering

Bachelor Of Science (B.S.), Biomedical Engineering