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Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
Lächelnde Mitarbeiterin im Gespräch mit Kollegin im Büro
ID: 134422

Development Engineer

  • MedTech
  • Asap
  • Laser Welding, Fixture & Tool Construction
  • K-Recruiting GmbH
Ansprechpartner:

Julius Strack

+49 89 1890998-21

julius.strack@k-recruiting.com

Overview

Availability
Asap, 40h/week, onsite & remote
Qualification
State-certified Mechanical Engineering Technician
Language Skills
German (native), English (business fluent)
Relevant Expertise
Laser welding, Fixture construction, Tool construction, SolidWorks, Process optimization, Automation solutions, Technical documentation, ISO 13485, MDR

Key-Facts

  • Extensive experience in fixture and tool construction, he focuses on developing precise solutions for medical technology applications from test fixtures to production-ready tools

  • Comprehensive expertise in SolidWorks for designing complex medical devices including efficient modeling, variant design and implementation of challenging geometries

  • Demonstrates high proficiency in technical documentation according to ISO 13485 and MDR, ensuring the creation of compliant documents for development, approval and audits

  • Excels in developing and integrating automation solutions that enhance assembly, testing and manufacturing processes, leading to sustainable optimization

Extract from Previous Activities

Selfemployed Consultant

Development Engineer

  • Design and further development of medical devices, fixtures, and tools

  • Creation of technical documentation according to ISO 13485 and MDR

  • Development and implementation of automation and process solutions in manufacturing

Medical Device Company, Germany

Development Engineer

  • Development of fixtures and tools to support testing and assembly processes

  • Constructive further development of modular patient monitors and defibrillators using SolidWorks Conducting concept and detailed designs considering ISO 13485 & MDR

  • Planning, setup, and evaluation of validation and verification tests to ensure product quality

  • Close collaboration with interdisciplinary teams in electronics, software, and quality management

Medical Device Company, Germany

Development Engineer

  • Independent constructive further development of stone extraction catheters for therapeutic endoscopy

  • Development of an innovative design for reliable and tight connection of latex and silicone tubes

  • Proven experience in catheter development including design, material selection and manufacturing technology

  • Planning, execution, and evaluation of functional and load tests to validate product requirements

  • Creation of technical drawings, specifications, and documentation according to ISO 13485

  • Subproject management with responsibility for technical implementation, scheduling, and coordination with internal development, quality, and manufacturing teams

  • Support in implementing process optimizations and automation solutions in the production environment

Medical Device Company, Germany

Development Engineer

  • Optimization of manufacturing and assembly processes and development of automation concepts

  • Constructive further development of operating tables and attachments with Siemens NX and Teamcenter

  • Project management for the conversion of surface coatings and materials focusing on cost optimization and sustainability

  • Creation, maintenance, and adaptation of technical documentation according to ISO 13485 and MDR requirements

  • Coordination of quality management, regulatory affairs, manufacturing, sales, and product management departments

Medical Device Company, Germany

Freelance Development Engineer

  • Design, further development, and transition of instruments to series production including development of suitable manufacturing technologies

  • Development and design of robotically-assisted surgical instruments and sterile cover sets with Inventor 2021

  • Developmental support of suppliers on-site including manufacturing optimization and process validation

  • Creation of technical drawings and specifications, compliance with standards and guidelines

  • Support in process optimization and documentation within the framework of MDR-compliant approval