Consultant
Current
Examples of activities
Strategic
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• Definition and documentation of R&D Product Development processes
◦ Specification of R&D-friendly processes
◦ Conforming to 13485/14971/FDA 820.30 requirements for Design Controls
◦ Incorporating V-model, Agile principles according to the product and organisation structure.
◦ Integration of QE and R&D activities.
◦ Specific experience: Radiometer ApS, LivaNova GmbH, iO Lifescience LLC
• Implementation of Requirements Management Process/Tool
◦ Assist company in defining requirements for and implementing an RM process and tool
◦ Specific experience: Radiometer ApS
• Product Architecture Mapping and Optimisation
◦ Gap analysis and proposals for improvement based on company’s product roadmap
◦ Specific experience: Radiometer ApS, LivaNova GmbH
Execution
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• Systems Engineering activities on Medical Device
◦ Requirements/Risk Management and documentation
◦ Architecture definition and interface specification documentation
◦ Remediation of Design Controls documentation
• Simulation and product performance prediction
◦ System-level modelling of electro-mechanical concepts
◦ Analysis of budgets of force/energy for electrical/hydraulic/mechanical systems
◦ Including tolerances and Monte Carlo analyses of production variation
◦ Finite Element Analysis
◦ Kinematic and compliant analysis of mechanism concepts
◦ Complex mechanical statistical tolerance analyses
• Mechanical concept development/troubleshooting/optimisation
◦ Robust design/Design-For-Manufacturing assessment and improvement
Example profiles
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1. Lead Systems Engineer for complex Medical Device development, with passion for process improvements.
2. Lead Mechanical Design Engineer, specialising in simulation and robust design.