Jeff Norton Email & Phone Number

Menlo Park, California, Us

Burlingame, Ca, Us

Medical Device Engineer Providing design and project management services

San Carlos, Ca, Us

Minneapolis, Mn, Us

Warsaw, Indiana, Us

(POST M&A OF RELIGN)Provide technical design, project scoping, scheduling and demand planning for post-acquisition product manufacturing scale-up, mentoring a team of junior engineers, and managing up-to six concurrent projects• Lead daily international and domestic engineering calls across Quality, R&D departments, and IP portfolio reviews• Complete redesign of flagship product, integration and making more components injection-moldable, resulting in 30% per unit cost reduction

Campbell, California, Us

• Project manager for product improvements, inclusive of design, product scope, and process improvements; led to 60% increase in sales across six months during COVID-19 quarantine, making the company more desirable for its acquisition • Led product validation soft launch and gathered feedback; redesigned product in < three months and sold 5k units in 2020• Developed and mentored team of junior engineers and responsible for 19 patents issued related to medical applications• Maintained product quality by leading and assisting with issues related to performance, standards, compliance, CAPAs, and customer complaints, and improving manufacturing processes through on-site visits to manufacturing facility in China• Successfully launched two novel products through all phases of design from NPI to validation and commercialization

Campbell, California, Us

• Launched startup company, redesigned, and innovated company’s flagship product, working with multi-disciplinary team and developing engineering specifications and design concepts; increased market scope, resulting in 40% sales growth• Designed and assembled components, assemblies, and systems of basic prototypes for feedback and testing; identified technical problems, determined, and executed resolution plans, improving product design verification and validation• Strong familiarity with cGMP, 21 CFR part 820, ISO 13485, and 14971 guidelines, Letter to File, and FDA 501(k) submission• Conducted testing for product package transit and shelf-life integrity, creating and approving Engineering Change Orders

Campbell, California, Us

• Worked remotely, communicating with suppliers to produce working prototypes for NPI, engineering testing on organic tissues, and contributing to designs and drawings, product scoping, planning, and schedules while completing coursework• Instructed technical support staff regarding testing and build requirements, developed engineering tests, measurements, and analysis, participated in design reviews, and determined end-user needs through direct observation and discussions

Campbell, California, Us

• Developed product and system-level specification requirements, utilized SolidWorks to create 3D models, assemblies, simulations, and engineering drawings, familiar with QA standard practices, cadaveric and in-vivo experience• Experienced with overseas manufacturing (Suzhou, China) and ISO 4 Class 10,000 cleanroom manufacturing requirements

San Luis Obispo, Ca, Us

• Led groups of 20 college students on how to safely perform laboratory exercises and experiments• Created laboratory report guidelines for students to follow and instructions on how to operate laboratory equipment

• Led complete reorganization of R&D labs, including adding budget and improving organizational infrastructure; resulted in improved laboratory equipment, reduction in lost time, and a safer and more efficient work environment• Aided in the design and development of radio frequency medical devices and technologies, and facilitated the procurement of specialty materials during the prototype phases; logged 300+ hours of medical device regulatory testing

Bachelor’S Degree, Industrial Technology

Engineering

Business Administration, Management And Operations, Mathematics