Mychael Medina

About Mychael Medina

Product-focused mechanical engineer with 9 years developing hardware and medical devices across the full lifecycle—from early-stage R&D through regulatory approval and commercial launch. Led integrated engineering, quality, and regulatory strategy at Cellmyx while previously managing cross-functional programs at Philips Respironics. Expertise in design controls, verification/validation, and bringing Class II medical devices to market under FDA and ISO frameworks. Track record of stepping into ambiguous problems, building processes that scale, and partnering effectively across technical and business stakeholders.I am also passionate about helping people and contributing to something larger than myself, which is why I enjoy using my technical expertise to innovate and to help further progress medicine and medical technology.Some of the experiences and skills I have gained professionally:Design Engineering • Mechanical Design • Project Management • Quality Assurance • Regulatory Compliance • Rapid Prototyping • Prototype Testing • ISO 13485/MDSAP Audit Management • Dimensional Tolerancing/Tolerance Analyses • Verification Testing • Validation Testing • Risk Analysis • Cross-functional Collaboration • CAD • Product Sustainment • Supply Chain/Logistics • Single Use Devices

Experience

1. Project Engineer, Quality & Regulatory Lead

   Cellmyx

   Oct 2024 — Present

   1) Manage main quality and regulatory responsibilities including but not limited to oversight and enforcement of SOP’s, coordinating QMS audits, compliance with regulatory bodies, etc.

Education

• Loyola High School

  H.S. Diploma

  2005 — 2009

• University of San Diego

  B.S./B.A., Mechanical Engineering

  2009 — 2014

Skills

• Fea
• Cad
• Pro/Engineer
• Machine Design
• Finite Element Analysis
• Tolerance Analysis
• Verification and Validation (V&V)
• Cnc Programming
• Design for Manufacturing
• Lathe
• Mill
• Biomechanics
• Manufacturing
• Ptc Creo
• Engineering Change Orders
• Microsoft Project
• Cnc
• Spine
• Change Orders
• Computer-Aided Design (Cad)
• Autocad
• Risk Analysis
• Windchill
• Geometric Dimensioning & Tolerancing
• Rapid Prototyping
• Mechanical Engineering
• Medical Devices
• Cam
• Fixture Design
• Creo
• Machining
• Pro Engineer
• Gantt Charts
• Cnc Manufacturing
• Microsoft Office
• Mechanical Design
• Gd&T