Martin Aicher-Medical Technology, Sensor Technology, Technical Optics, CAD, Implants, Endoprosthetics, Instruments

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Experience
Martin Aicher
Summary
As a Medical Technology engineer (Dr.-Ing.) and experienced surgical mechanic, product developer and designer, I combine deep technical know-how with many years of hands-on experience in developing innovative products. My focus is on development, design and industrialization as well as regulatory affairs / approval of highly precise products in the fields of medical technology, precision engineering and mechanical engineering. I have proven expertise in:
- Technical skills
- Product development & design of complex medical and precision engineering systems
- Biocompatible materials, sensor technology, microsystems engineering and technical optics
- CAD-based design, precision engineering, fluid and flow mechanics
- Manufacturing technologies including injection molding, precision mechanics and transfer to series production
- Regulatory & Quality
- Usability engineering according to EN 62366-1
- Risk management according to ISO 14971
- Quality management according to ISO 13485, ISO 9001
- Solid experience with MDR and FDA requirements
- Project management & development
- Certified IPMA project manager
- Leading interdisciplinary development projects
- Research experience in medical technology, sensor technology and technical optics
- Summary I stand for precise technical solutions, regulatory certainty and efficient project execution. With my combination of scientific depth, hands-on experience and regulatory insight, I help companies develop innovative medical technology products quickly, safely and in compliance with the market.
Skills
Areas Of Expertise
- Medical Technology
- Sensor Technology
- Technical Optics
- Mechatronics
- Microsystems Technology
- Biocompatible Materials
- Methodical Product Development
- Implants And Endoprosthetics
- Project Management
- Quality Management Ipma
- Regulatory Affairs
Projects – Technical Optics
- Microscopy
- Endoscopy
- Immersion Optical Systems
- Optical Sensors
- Light Guides
Projects – Medical Electronics And Active Medical Devices
- Electromagnetic Therapy Devices For Microcirculation Of Blood Vessels
- Electric Drives, Precision Mechanics Motors
- Embedded Devices, Medicine 4.0 / Industry 4.0
- Feasibility Studies, Prototype Design, Electromechanical, Chemical And Hydrodynamic Characterization Up To Series Maturity
- Structural Integration Of Motors For Pump Systems
- Integration Of Motors For Catheter Drives
- Implantable Drive Systems With Motors
- Bone Saws With Maxon Motors
- Osteosynthesis Implant (Bone Implant) With Linear Drive
- Electromagnetic Therapy Devices For Microcirculation Of Blood Vessels
- Gold And Platinum Substitution For Electrodes
- Electrochemical Impedance Spectroscopy (Eis)
- Characterization And Development Of Battery Cells And Li-Ion Batteries
- Biocompatible Materials: Stainless Steel, Titanium, Nitinol, Polymers, Ceramics, Composites
- Vacuum Device With Pumps For Wound Healing
- Braided Tubes (Reinforced Hoses)
- Shaft Instruments And Trocars
- Surgical Instruments, Minimally Invasive Instruments (Mic)
Projects – Analytical Instruments, Sensors And Fluid Preparation
- Monitoring Systems
- In Vivo Diagnostics (Ivd)
- Inline Measurement Systems For Monitoring And Analytical Devices
- Feasibility Studies, Prototype Design, Electrochemical And Hydrodynamic Characterization Up To Series Maturity
- Electrochemical Deionization (Edi) As A Monitor
- Membrane Technology
- Measurement Method And Control Of Carbide Saturation In Cooling Water
- Ph Sensor
- Optical Sensors With Laser Diodes And Leds
- Dissolved O2 Sensor
- Co2 Sensors
- Ion-Selective Sensor (Ise)
- Conductivity Sensors
- Turbidity Sensor According To Iso 7027
- Biosensors
- Flow And Pressure Sensors
- Gold And Platinum Substitution For Electrodes
- Electrochemical Impedance Spectroscopy (Eis)
- Biocompatible Materials: Stainless Steel, Titanium, Nitinol, Polymers, Ceramics, Composites
Design And Development
- Design Of Plastic Injection-Molded Components And Housings
- Calculation And Design Of Fluid Channels
- Design Of Metal Die-Cast Components
- Design Of Sheet Metal Parts
- Implants And Prostheses
- Endoprosthetics: Knee And Hip Endoprostheses
- Bypass Implants
- Nitinol Stents
- Bone Plates
- Dental Implants
- Precision Meshes
Instruments For Medical Technology
- Angioplasty: Ptca Percutaneous Transluminal Coronary Angioplasty With Balloon Catheter
- Catheter System As Minimally Invasive Heart Pump
- En Iso 10555-4: Intravascular Catheters
- Braided Tubes (Reinforced Hoses Through Precision Meshes)
- Thrombectomy With Rotablation Catheter
- Trocars
- Surgical Instruments, Minimally Invasive Instruments (Mic)
- Endoscopes Iso 8600-1, En 60601-2-18, En 62471
Regulatory Affairs For Medical Devices
- Ce For Europe (Class Ii And Iii), Eu Medical Device Regulation 2017/745 (Mdr)
- Eu Regulation 2017/746 For In Vitro Diagnostics (Ivdr)
- Ensuring Complete Documentation According To Current Regulatory Requirements
- Fda Registration And Approval 510(K), Pmn, Pma, Class Ii, Iii
- Design History Files (Dhf), Device Master Record (Dmr), Device History Record (Dhr)
- Internal And External Audits
- Fda And Ce Audits
- Mock Audits
- Requirement Engineering, User Requirement Specifications, Functional Requirement Specifications
Quality Management And Relevant Standards For Medical Technology
- En Iso 9001:2015
- En Iso 13485:2021
- Usa Fda 21 Cfr 820 Quality Management System
- Fda 21 Cfr §§ 803, 806, 807, 830
- In Vitro Diagnostics (Ivd, Ivdr) Fda 21 Cfr §§ 600, 610, 660
- Usa Fda Risk Management For Medical Devices Din En Iso 14971:2019
- P-Fmea For Production
- Usability Of Medical Devices En 62366-1:2021
- Capa (Corrective And Preventive Action) And Gmp
- Medical Electrical Equipment En 60601-1:2013
- Emc For Medical Devices Din En 60601-1-2:2022
- Medical Device Software En 62304:2018
- Cell Culture In Cleanroom With Different Cell Lines For Biocompatibility Testing Of Polymers And Alloys
- Biological Evaluation Of Medical Devices En Iso 10993
- Clinical Investigation Of Medical Devices Iso 14155
Manufacturing Technology And Processes
- Process Qualification And Validation
- Injection Molding Technology
- Cnc Micromechanical Manufacturing
- Microsystems Technology, Printed Circuit Boards (Pcb)
- Joining Technologies: Laser Welding Of Titanium, Stainless Steel, Plastics As Well As Gluing And Ultrasonic Welding
- Evaluation, Setup And Qualification Of Equipment
Thin Film And Surface Technology
- Coating Of Implants And Tribological Surfaces With Chemical Vapor Deposition (Cvd) And Physical Vapor Deposition (Pvd), Sputtering Of Precious Metals, Stainless Steels, Nitinol, Titanium Alloys, Polymers And Ceramics
- Plasma Technology For Functional Coatings: Hydrophilic And Hydrophobic Surfaces
- Nanotechnology: Surface Functionalization: Self-Assembled Monolayers (Sam)
Product Life Cycle Management And Simulation
- Product Life Cycle Management
- Finite Element Method
- Ansys Fem: Structural Mechanics, Statics
- Ansys Fem: Fluid Mechanics, Flow Simulations
- Ansys Fem: Electrical Engineering, Electromagnetic Fields
Characterization And Testing Of Microelectronics
- Pcb (Printed Circuit Board)
- Sensor Technology
- Microcontrollers
- Can Bus: Iso 11898, Sae
- Control And Data Management With Labview And Matlab
Software, Cad And Documentation
- Programming Language Python 3.14
- Autodesk Inventor
- Pro/Engineer, Ptc Creo Parametric
- Solidworks
- Siemens Nx
- Solid Edge
- Standards-Compliant Technical Drawings
- Endurance Tests, Mechanical, Fluid Mechanical, Electrical And Chemical Characterization
- Verification, V-Model, End Of Line (Eol) Testing
- Writing Work Instructions For Production, English Regulatory Documents And Scientific Articles
- Support Of Clinical Studies
- Data Processing, Digital Data Management And Statistics
- Professional Handling Of Microsoft Office Applications: Powerpoint, Word And Macro Programming For Excel
Languages
Education
Dr. Ing. · Medical Technology
M.Sc. · Medical Technology
Dipl. Ing. (FH) · Medical Technology
Statistics
Experience
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Martin is based in Zürich, Switzerland.
Martin speaks the following languages: German (Native), English (Advanced).
Martin holds a Doctorate in Medical Technology, a Master in Medical Technology and a Bachelor in Medical Technology.
The availability of Martin needs to be confirmed.
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