Design Control Engineering

ID1013

Senior Consultant Medical Device

MSc. UK
Available for: Tasks

Competences

  • Medical Deviceproduct development processes
    R&D process design conforming to ISO13485, ISO14971, FDA 820.30 QSR etc.
    Remediation of product documentation.
  • Systems Engineering, requirements and traceability
    Authoring, management and traceability of requirements.
    Design and documentation of product architecture.
  • Concept development and robust design principles
    Design for Manufacturing, tolerance analyses.
  • Performance simulation
    Mathematical modelling, system simulation, Monte Carlo analyses.

Key results

Principal member of successful MDR remediation team (DE)
Compiled DHR Design Input/Traceability documentation for heart-lung machine OEM, prior to successful MDR audit.

Design Controls and R&D process mapping (Radiometer, DK)
Leader of Design Controls expert working group, working to improve development processes within regulatory framework.

Requirements Management tool implementation (Radiometer)
Led activities to select and implement RM tool, PTC Integrity.

Advanced suspension systemslead: Magneti Marelli (IT)
Led specialist team developing new concepts from idea to on-car track testing –resulting in 8+ successful patent applications.

Certifications/Knowledge/Tools

Certifications

  • INCOSESystems Engineering certification –ASEP level

Regulatory: thorough knowledge of

  • ISO 13485, 21 CFR 820 (QSR, Design Controls)
  • ISO 14971 (Risk Management), IEC 62366 (Usability)
  • IEC 60601 (Safety of Electrical Medical Equipment)

Tools

  • CAD: PTC Creo, Fusion360
  • FEA/MBS: PTC Mechanica, Nastran, Creo Multibody,ADAMS•System Simulation: MapleSim, Maple
  • Requirements Management: PTC Integrity, Siemens Polarion
  • Programming: Java (hobby), Visual Basic, Fortran

Personal Characteristics

He is a career technical specialist, focussing on Systems Engineering of complex Medical Device products. His knowledge and experience places him directly at the interface between R&D and QA–often a pain point for Medical Device companies arising from poor mutual understanding of each other’s needs and drivers – allowing him to contribute with both the glue and the grease which the development process needs.

He strongly believes that good processes hold the key to good products, and that a first principles understanding of stakeholders’ needs combined with first-rate visual communication are the key to good processes. And that good documentation is a natural outcome of good processes.

He enjoys his work, is versatile, passionate about delivering high quality engineering withclear communications, and is motivated by technical challenge, learning new skills and enjoyable teamwork.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com