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.

Engaged through EPM Scientific for a Medical Device OEM in Munich, Germany working on DHF Remediation.• Principal member of MDR Remediation team• Responsible for creating Design Input/Requirements documentation and traceability• Responsible for System Architecture structure and documentation• Various specialist studies for remediation effort and R&D

iO life science offers a lean and responsive medical device engineering service, with nodes in the Bay Area, Munich, Basel and Pune, that spans the entire development process, from capturing user needs to undertaking design transfer. It helps both start-ups and respected brands develop innovative and patient-centric products, all within the applicable regulatory framework using our ISO 13485-certified QMS. Novartis, AbbVie and AstraZeneca have already trusted us as a development partner.• Business building activities, development of customer and supplier network• Responsibility for management, Systems Engineering and Design Controls for client projects based in EU

Valcon Design is an engineering consultancy with the mission of increasing the predictability of the outcome of the product development process, and achieve this by developing methods and tools to support the engineering process, gathered under the Six Theta® brand. These tools are directly focused on improving design robustness, manufacturability, time-to-market and innovation, and customer companies can receive either direct support using these tools or training in how to integrate them into their own product development process. Valcon Design's activities are perfectly aligned with my own professional interest in design methodologies, and specifically those associated with Systems Engineering and interface specification, robust design and elasto-kinematic mechanism definition. My role as Chief Engineer was focused on supporting customer projects, typically with system analysis, simulation and calculations, as well as involvement in training at all levels of the Six Theta programme.• Consulting and training clients in robust design (Design for Manufacture, tolerance calculations etc.)• System simulation and analysis; FEA, MBS, 3D tolerance calculations, statistical modelling

Responsibilities in connection with both execution and R&D competence development in the areas Systems Engineering and Design Controls. ACTIVITIES AND RESPONSIBILITIES• Leading a small expert team performing and documenting Requirements Analysis and Risk Management (ISO14971) for a medical device (IVD) project.• Mechanism design and simulation during development of new instrument. • Ownership of various mechanical modules during development phase. • Leading a small expert team developing and strengthening the product development process with focus on Design Controls and collaboration between QA and New Product Development. • Industrial adviser for a PhD project concerning the definition of interfaces in complex multi-technology products. • Selection and early implementation of requirements management tool (PTC Integrity).PUBLICATIONS• “Defining Interactions in Complex Multi-Technological Products – A Physics-based, First Principles Approach” (co-author with Jakob Parslov, paper currently under review)TRAINING HIGHLIGHTS• MIT “Systems Engineering and Architecture: Principles, Models, Tools, and Applications” (2015, 5 days)• MIT “Product Platform and Product Family Design: From Strategy to Implementation” (2014, 5 days)• ITOS “Systems Engineering Masterclass” (2013, 3 days)• ITOS “Masterclass: Defining Requirements” (2014, 5 days)• AAMI “Design Control Requirements and Industry Practice” (2014, 3 days)• AAMI “Human Factors and Usability Engineering” (2015, 3 days)

• Innovative, practical solutions to suspension system design briefs, combining sound engineering practice with thorough First Principles understanding.www.gerrard.dk

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~SUMMARYConceived and managed a series of projects concerning innovative suspension architectures from proof-of-concept studies, through detailed design to supervision of prototype build and testing of technology demonstrator cars. Other activities involved the definition of suspension design methodologies and business development activities.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~IN MORE DETAIL...Responsible for a small innovation team working on suspension architectures• Proof of concept studies• Detailed design of prototypes• Supervision of prototype build and on-track testing of demonstrator vehiclesProposed concept of flexible structural components to reduce cost and enhance K&C• Examples of which being the FLECS, TORCS and U-Link architectures• Demonstrator cars acclaimed by Ford, Nissan, PSA, Mercedes, VDI magazine and othersDevelopment of kinematic and compliant linkage design methodologiesFrequent participation in business development activities• OEM presentations, drive appraisals, lectures, exhibitions etc.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Patents• Sole inventor on 6 pending and 3 granted, including those for the FLECS, TORCS and U-Link suspension architectures. Awards• 2007 Frost & Sullivan Chassis Innovation Award – FLECS• 2007 SAE Arch T. Colwell Merit Award – SAE paper 2005-01-1719Papers• SAE 2005-01-1719, FISITA F2004F301, SAE 2002-01-0281Articles• "Suspension Architectures Design"​ - series of three articles, Nov '05 to Mar '06, "Ingegneria dell'Autoveicolo" (ATA, Italy)~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~SUMMARYBoth project leader and project engineer for the UK suspension systems and vehicle dynamics consultancy, having responsibility for and contributing to a wide variety of design projects, trouble-shooting exercises and proof-of-concept studies in various vehicle sectors.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~IN MORE DETAIL...Management and execution of concept design, analysis and trouble-shooting projects for customers ranging from DaimlerChrysler, VW-Audi, Tata, Iveco, Rolls-Royce and Bentley, Visteon and MCI (Motor Coach Industries). Projects included...• Concept studies: Rolls-Royce & Bentley, DaimlerChrysler, IVECO...• NVH troubleshooting: Visteon, Rolls-Royce & Bentley ...• Production designs: Motor Coach Industries, Rolls-Royce & Bentley, Rover ...• Consulting services : Tata Technologies (Indica/Indigo) ...• Simulation/modelling: Audi AG, Heil Trailer International, Vickers Defence Systems ...Key projectsThe design of the suspensions for the MCI coach “Renaissance” (tri-axle North American tour coach) plus development testing in US/Canada, creation of the ACC suspension architecture, collaboration with Tata on the Indigo (Indica sedan) rear suspension, handling simulation models for both military and commercial vehicles, driveline installation project for Bentley Motors, and the design of a successful rally-car rear suspension. Technical activities including CAD, MBS (Adams), FEA, onsite vehicle development workHeavy involvement in business development activities: presentations to prospective clients, conferences etc.~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Patents• Sole inventor for the ACC suspension architecture. Papers• SAE 1999-01-0046, IMechE C513 008 96~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

CAE engineer in Jaguar Cars' R&D group, performing structural and modal analyses (Nastran, ABAQUS etc.) on suspension and engine mounting components.

Undergraduate sponsorship programme involving a total of 18 months work experience in 6 different departments within Ford around the UK before and during the BSc degree programme.