03.11.2026 aktualisiert
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Senior Consultant & Interim Manager Design and Development | Medical Devices & Implants
Hambühren, Deutschland
Weltweit
Dipl.-Ing. (FH) Precision Mechanic EngineerÜber mich
Senior Expert Medical Device Design and Development. Deep expertise in developing active implantable medical devices (class 3), including infusion pumps and disposable systems, with thorough knowledge of MDR and FDA regulatory documentation, risk management and design FMEA.
Skills
CAD Design & FEM Analysis
Extensive experience in creating detailed 3D CAD models using SolidWorks, performing FEM analysis and producing technical drawings for medical devices, implants, prosthetics and industrial systems.
Medical Device Development & Regulatory Compliance
Deep expertise in developing active implantable medical devices (class 3), including infusion pumps and disposable systems, with thorough knowledge of MDR and FDA regulatory documentation, risk management and design FMEA.
Production Process Development for Implants
Proven track record in developing and optimizing production processes for implants and disposables, including cleanroom layout (Class 7), laser welding of titanium, sterilization processes and supplier management.
Requirements Management
Systematic definition and management of system requirements and customer requirements across multiple medical and industrial development projects.
Prototype Assembly & Testing
Hands-on assembly of prototypes and execution of endurance tests and stress tests across various industries including medical technology, oil and gas, and laser technology.
Laser Technology & Optical Systems
Development of laser systems for various applications including laser ablation of biomedical sensors, stencil laser systems, laser imaging for flexo plates, and optical alignment on laser systems.
Supplier & Change Management
Management of supplier relationships and change control processes within regulated medical device development environments.
R&D Engineering
Broad R&D engineering background spanning medical systems, geoscience instrumentation, packaging systems and laser electronics, with a focus on innovation and product refinement.
Extensive experience in creating detailed 3D CAD models using SolidWorks, performing FEM analysis and producing technical drawings for medical devices, implants, prosthetics and industrial systems.
Medical Device Development & Regulatory Compliance
Deep expertise in developing active implantable medical devices (class 3), including infusion pumps and disposable systems, with thorough knowledge of MDR and FDA regulatory documentation, risk management and design FMEA.
Production Process Development for Implants
Proven track record in developing and optimizing production processes for implants and disposables, including cleanroom layout (Class 7), laser welding of titanium, sterilization processes and supplier management.
Requirements Management
Systematic definition and management of system requirements and customer requirements across multiple medical and industrial development projects.
Prototype Assembly & Testing
Hands-on assembly of prototypes and execution of endurance tests and stress tests across various industries including medical technology, oil and gas, and laser technology.
Laser Technology & Optical Systems
Development of laser systems for various applications including laser ablation of biomedical sensors, stencil laser systems, laser imaging for flexo plates, and optical alignment on laser systems.
Supplier & Change Management
Management of supplier relationships and change control processes within regulated medical device development environments.
R&D Engineering
Broad R&D engineering background spanning medical systems, geoscience instrumentation, packaging systems and laser electronics, with a focus on innovation and product refinement.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2014
Sprachen
DeutschMutterspracheEnglischgut
Projekthistorie
Design of implantable Drug Delivery System (infusion pump), system and customer requirements definition, production process development for implants, catheter systems and disposable sets, sterilization of implants and disposables, injection needles, silicone gaskets, microfluidic chips, titanium nested rippled bellows, implantable batteries, laser welding of titanium in Class 7 cleanroom, cleanroom layout for implant production, risk management, supplier management, change control, MDR and FDA regulatory documentation.
Refinement of a disposable tubing set for CSF drainage, creation of detailed CAD models, FEM analysis and drawings, requirements management and design FMEA. Applied technologies: 3D CAD SolidWorks and MS-Teams.
Development of active class 3 implant (infusion pump) for pain therapy, creation of detailed CAD models, FEM analysis and drawings, requirements management and design FMEA.