Roei Mayo Email & Phone Number

United States

Irvine, California, United States

Working on early-stage medical device development in the Advanced technology group

Israel

Working on early-stage medical device development in the Advanced technology group • Working closely with a cross-functional team including physicians and marketing with Bio-design methodology • Reporting to innovation Sr. Director leader, including periodic updates to senior leadership • Managing (indirectly) up to 3 engineers and technicians under rapid design and testing sprints • Leading rapid proof-of-concept prototyping of implants and delivery systems for unusually complex technical problems (ex-vivo & in-vivo)• Conducting research activities such as literature and anatomical reviews, • Designing computational, analytical, and bench DOEs

• Working on novel and innovative solutions to heart failure problems in the new Edwards Israel Innovation Center (EIIC).• Design – Leading Delivery system from concept to functional product, jigs, and fixturesdevelopment for V&V and for the overseas manufacturing process.• Project management – leading multidisciplinary activities with time frames, budgets, and prioritiesconsiderations in the highest international standards of the medical device.• Product lifecycle – production optimization and yield improvement. Treatment of failures,complaints and CAPA handling and multinational large-scale operations and ECOs.• Design testing and experiments – planning, performing, and writing of protocols and reports.• Provides mentoring and guidance to employees. Acts as an expert providing direction andguidance to process improvements and establishing policies• Effectively interact with other departments & organizations (e.g. QA, Operations, Sales, Purchasing,Product Management, Marketing, and Suppliers)• Supply chain – Understanding of supply chain management and method as well as resolvingquality, labeling, packaging and distribution issues.

Israel

• Complex valve repair and replacement, devices for the treatment of mitral and tricuspid valve regurgitation. Reconstruction implants similar to a surgical annuloplasty mitral valve repair device, with a transcatheter approach.• Design – Leading Delivery system from concept to funcional prodcut, jigs and fixtures development for V&V and for the overseas manufactuing process. • Project management – leading multidisciplinary team with time frames, budgets, and priorities considerations in the highest international standards of the medical device. • Product lifecycle – production optimization and yield improvement. Treatment of failures, complaints and CAPA handling and multinational large-scale operations and ECOs.• Design testing and experiments – planning, performing, and writing of protocols and reports. • Provides mentoring and guidance to employees. Acts as an expert providing direction and guidance to process improvements and establishing policies• Effectively interact with other departments & organizations (e.g. QA, Operations, Sales, Purchasing, Product Management, Marketing and Suppliers)• Supply chain – Understanding of supply chain management and method as well as resolving quality, labeling, packaging and distribution issues.

• Mechanical leader – leading full development projects (from MRD to TTP according to ISO 13485:2016), design mechanical drawings, jigs and tooling for a cleanroom environment. Writing development documents: requirements, specifications, risk analysis.• Project management – managing several subcontractors (time frames, budgets, and priorities considerations) leading transfer to production projects (process validation – IQ/OQ/PQ, certify suppliers and training) including DMR and DHF management.• R&D testing and experiments – planning and performing V&V. Planning animal study (R&D). Writing protocols and reports. • Electrical design– board design considerations according to IEC 60601-1 requirements, performing EMC tests according to IEC 60601-1-2 (2014).• QA & RA – establishment and maintenance of tech file for CE submission and assisting in FDA (510k) submission. Participating in ISO 13485:2016 audit. Adjustment of QMS according to MDSAP requirements (chapter 5 – D&D). • Product lifecycle – production optimization and yield improvement. Treatment of failures, complaints and CAPA handling.

• Performing computerized experiments – numerical simulations, including CFD and FSI, using Linux-based servers.• Drafting and designing – drafting and designing testing systems, performing practical experiments for validation purposes.• Data processing – working with MATLAB and Office for analyzing and presenting information.• Scientific reading and writing – writing articles according to international standards.• Tutorial – frontal and personal instruction, devising lesson plans and presentations, public speaking in Hebrew and English.• Collaboration - clinical work with physicians at Ichilov Hospital and teams from the US and China; utilizing protocols.

Graduated with honors. Courses included: Fluid Mechanics, Dynamics, Statistics, Aeronautics, Control Systems, Circuits, Physics Labs, Materials & More.

Fixing advanced Cellular problems. Reading Sheets. Soldering.

Being a "father/big brother/ teacher/ cop/ psychologist/ and a friend" to kids from social services from ages 8-18. Meeting with them at there own houses on a weekly basis.

Master Of Science (M.Sc.), Mechanical Engineering

Excel students program who start the master degree at their last year of the the B.Sc. Emphasis in Biomechanics. Experience with Final.

Bachelor Of Science (B.Sc.), Mechanical Engineering

With emphasis in Aeronautics and computational mechanics.

Course Manager/ Instractor, Navy, Radars & Microwaves

Extended Matriculation, Electronics, Computer, Physics