FMEA Experts in Switzerland
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Meet FRATCH Experts in Switzerland, who have recently used FMEA
Oliver W.
Last position:
Specialist Planner / Cleanroom Planning Lead at Major Aircraft Manufacturer
- Start-up and commissioning of the cleanroom
- Certification of the cleanroom
Hendrik B.
Last position:
Senior Mechanical Engineer Medical Devices at Roche Diagnostics AG
- Concept and optimization of medical devices
- Design of housing segments, coupling systems and complex mechanical systems
- Plastic and sheet metal design
- Supplier inquiries and technical evaluation
- Technical support for suppliers and production
- CAD modeling with CATIA V5 and SolidWorks
- Creating models, drawings according to ISO GPS and documentation
- Approvals in PLM and SAP
- Internal coordination with relevant stakeholders
Hans S.
Last position:
Interim Manager, Consultant, Facilitator at Business Excellence Services GmbH
Interim manager, consultant, facilitator
Project management with focus on trouble shooting & customer care and/or product development/reengineering; regulatory management
Supply chain; risk and quality management; people management
Experienced within medical device; aerospace; packaging; small- & large equipment; optical- & electrical-systems; metal & plastics; free auditor
Since 2016, working for various accredited organizations as a freelance auditor regarding systems according to ISO 13485 and ISO 9001
2023-2024: Medical device product development, supply-chain and regulatory set-up with regard to a medical device re-engineering/launch and manufacturing
2023-2024: Project trouble shooter & customer care in the European aerospace industry within precision optics systems manufacturing; project risk and validation management including software validation
2022: Validation (FMEA, IQ OQ, PQ) management assigned with design and process risk assessment of complex electrical (IEC60601-1) mechatronics robots for MDR approval following ISO 14971
2022: Interim head of QM in aluminum-foil deep drawing process improvement; people and international Nespresso supplier quality management
2021-2022: Cytiva Cell Therapy greenfield project; assigned with design and implementation support of a certification, validation, GMP commissioning strategy for the technical infrastructure, e.g., clean rooms
2020-2021: Interim QA-Leader in Denmark assigned with the software release, manufacturing and distribution of Class IIb laser equipment for Candela, including international notified body and manufacturing transfer project
2020: Quality support and interim quality management for a manufacturer in the IVD test equipment supply chain and dialysis supplies in Bavaria
2018-2020: Expert/SME in Q-Management/Q-Engineering for orthopedic and arthroplasty device and tool production: turning, milling, cleaning, surface treatment and sterile packaging
2017: Re-engineering of the Medela product development process regarding cGMP 21CFR820.30/ISO 13485:2016 and MDR design control requirements for soft and hardware design regarding Class IIb pumps
2017: MDSAP preparation support and mock-audit coaching
2016: Interim senior QE-Expert for Maquet extracorporeal circulation devices manufacturing as ISO 14971 risk and change management expert in a Roche CAPA remediation and compliance project of IVD blood analyzers/gas sensor production
2016-2017: Orthopedic and arthroplasty implants design history file (DHF) review regarding compliance to 21 CFR 820.30 design control requirements
2015: Assigned by Novartis with design control for a new parenteral drug delivery system; manufacturability assessments during design evaluation; assessing potential plastic injection molding and/or high-volume assembly contractors in Europe and the US
2014: Assessing/auditing metallurgy process validation (IQ/OQ/PQ) of Zimmer contract manufacturers around Europe for FDA audit readiness; Depuy-Synthes subject matter expert (SME)
2013-2014: CAPA-8D process reengineering and setting in place/training new EtQ software tools; coaching of project and product managers in working through individual CAPAs; remediation of global legacy CAPAs; supporting complaint and field action (FSCA) management
2012-2013: QA/RA Manager at Sias AG for in vitro diagnostics (IVD) liquid handling robots manufacturing; led small team for electrical safety CE/CB scheme product approvals; QMS, change and CAPA management
2011-2012: Site Quality Manager at Medtronic for drug eluting balloon and Nitinol stent-catheter manufacturing; quality operations including Q-engineering and control; led 15 direct and indirect reports
2009-2010: Supported quality initiatives in medical device industry; assessments and audits for manufacturers and suppliers as a consultant of Business Excellence Services
Robert O.
Last position:
Interim SQM Plastics at Thyssenkrupp Automotive
- Supplier management
- SQI audits
- Sustainability
Martin A.
Last position:
Martin Aicher
Main areas of activity ⋅ Martin Aicher
Areas of expertise
Medical technology
Sensor technology
Technical optics
Mechatronics
Microsystems technology
Biocompatible materials
Implants and endoprosthetics
Project management
Quality management IPMA
Regulatory affairs
Education
Dr.-Ing. Medical Technology
M.Sc. Medical Technology
Dipl. Ing. (FH) Medical Technology
Surgical mechanic, precision mechanic
Methodical product development
26 years of research, development, verification and agile product development
5 years of hands-on manufacturing of micromechanical instruments and implants
Projects
Development and verification of technical optics
Microscopy
Endoscopy
Immersion optical systems
Optical sensors
Light guides
Device development — medical electronics, 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)
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 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
Finite element method
ANSYS FEM
Structural mechanics, statics
Fluid mechanics, flow simulations
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
Programming language
Python 3.14
CAD
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
© 2026 M. Aicher
Joachim Z.
Last position:
Technology & Production Support at Bruker Daltonics/Bruker Switzerland AG
- NPDI and lifecycle support for HPLC & MS devices for protein analysis
- Coordination of production transfers and change management
Discover over 15,000 top freelancers
Statistics of experts using FMEA
Aggregated from the professional profiles of matched freelancers.
Experience
30 years
Position duration
2.9 years
Positions per freelancer
13
Top business areas
Quality Assurance, Operations, Product Development
Top industries
Healthcare, Manufacturing, Aerospace and Defense
Certification focus areas
Quality Assurance, Information Technology, Operations
Bachelor's degree or higher
67%
Master's degree or higher
50%
Doctorate
17%
Certifications per freelancer
2
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 14 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Switzerland are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows the share of experts charging within that range.
Average rates of experts in Switzerland using FMEA
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 14 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
FMEA experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (100%)
- Manufacturing (100%)
- Aerospace and Defense (50%)
- Automotive (50%)
- Chemical (50%)
- Energy (33%)
- Banking and Finance (33%)
- Pharmaceutical (33%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
What FMEA covers
FMEA, short for Failure Mode and Effects Analysis, is a structured method for finding how a product, process or system could fail. Teams assess possible causes, effects and controls before problems reach customers or disrupt operations. The method supports preventive risk management from early design through production and service.
Main FMEA methods
Design FMEA examines risks in products and technical designs. Process FMEA focuses on manufacturing, assembly, logistics and service workflows. System FMEA considers interactions between subsystems, while Software FMEA applies the same reasoning to functions, interfaces and failure behaviour in embedded or connected products.
Typical deliverables
- Scope, boundary and functional analysis
- Structured failure mode, cause and effect assessments
- Risk prioritisation and recommended actions
- Prevention and detection controls
- Updated FMEA records linked to verification evidence
Strong work connects each risk to an owner, action, deadline and measurable confirmation. It also keeps assumptions, interfaces and changes visible throughout the project.
Tools and related skills
FMEA work often sits alongside quality management, systems engineering, requirements analysis and design reviews. Professionals may use dedicated quality software or structured templates, then connect findings with PLM, ERP, QMS, requirements and issue-tracking systems. Knowledge of control plans, process flow diagrams, fault tree analysis and root-cause methods adds practical value.
When companies need specialists
- A new product or process is entering design or industrialisation
- A customer, audit or internal review requires traceable risk analysis
- Recurring defects expose gaps in prevention or detection controls
- A plant, supplier or product line is changing significantly
Freelance expertise is useful when the work needs an impartial facilitator, short-term capacity or experience across engineering, production and quality teams. In Switzerland, collaboration may involve German, French, Italian or English, depending on the site and stakeholders.
What good expertise looks like
A capable professional does more than fill in a worksheet. They ask precise questions, separate failure effects from causes, challenge weak controls and prevent teams from scoring risks by habit. They understand the product or process well enough to distinguish critical risks from theoretical ones.
Quality also depends on facilitation. The right specialist brings operators, designers, quality representatives, suppliers and service teams into the discussion, records decisions clearly and follows actions through to closure. Remote workshops can work with prepared process maps and shared systems; on-site sessions are often better when observations, equipment and physical process steps matter.
Frequently asked questions
Before you brief your next project: the most common questions about FMEA.
FMEA is used to identify potential failure modes, their causes and their effects before failures occur. It helps teams improve prevention and detection controls, prioritise actions and maintain a traceable record of product or process risk.
Failure Mode and Effects Analysis can be applied at different levels. Design FMEA examines risks in product functions and specifications, while Process FMEA examines how manufacturing, assembly, logistics or service activities can create failures.
FMEA works from individual functions, steps or components toward possible effects and controls. Fault tree analysis starts with a defined top event and works backward through logical combinations of causes, so the methods often complement rather than replace each other.
A strong FMEA specialist usually understands quality management, systems engineering, requirements analysis and root-cause investigation. Experience with control plans, process mapping, fault tree analysis, change management and quality or product lifecycle systems is also useful.
The right Failure Modes and Effects Analysis experience depends on scope, risk and team maturity. A focused process review may need a facilitator who can work quickly with subject experts, while complex products require deeper knowledge of interfaces, requirements, verification and production controls.
FMEA workshops can be run remotely when process information, drawings, requirements and action tracking are accessible to everyone. On-site work is more effective when the specialist must observe equipment, operator activities or physical process conditions; language needs should match the Swiss site and stakeholder group.
Review whether the Failure Mode and Effects Analysis reflects real functions and process steps rather than generic wording. Good work links causes to specific controls, assigns practical actions, explains risk decisions and shows that completed actions changed the evidence or control system.
FMEA creates value when it influences design choices, process controls and verification activities before problems become expensive. The analysis should be updated after changes, incidents, supplier findings or new knowledge, and its actions should connect to the teams responsible for implementation.
The average hourly rate of freelancers in Switzerland who have used FMEA in their recent projects is 131 €, which corresponds to a daily rate of about 1,048 € based on an 8-hour working day.
Of the freelancers in Switzerland who have used FMEA in their recent projects, 67% hold at least a Bachelor's degree, 50% hold at least a Master's degree, and 17% hold a doctorate.
On average, freelancers in Switzerland who have used FMEA in their recent projects have 30 years of professional experience, with a single engagement typically lasting around 2.9 years.
The most common languages among freelancers in Switzerland who have used FMEA in their recent projects are German (100%), English (100%), and French (50%).
The most common industries among freelancers in Switzerland who have used FMEA in their recent projects are Healthcare (100%), Manufacturing (100%), and Aerospace and Defense (50%).
The most common business areas among freelancers in Switzerland who have used FMEA in their recent projects are Quality Assurance (100%), Operations (83%), and Product Development (83%).
Main locations of FRATCH Experts, who have recently used FMEA
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Countries:
Zurich Geneva Basel Bern Request a free demo
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FRATCH CEO
