Design Control Engineering

ID1022

Senior Consultant – R&D Design Control

MSc Mechanical Engineering
Available for: Full time, part time, tasks

Competences

  • Medical Device Development:
    • Syringes, injectors, pumps, IVD and monitoring systems including reagents, surgical instruments.
    • Mechanics, electronics, software and connectivity.
    • Design Control and QA:MDR, ISO 13485, 21 CFR820.30.
    • Risk analysis: ISO14971 -FMEA.
    • Experience with Root Cause Analysis, data mining and trend spotting.
    • Lab testing and analysis, Design of Experiments.
    • Test methods and measurement uncertainty:
      ISO 2859, ISO 3951, ISO 17025, BIPM, GUM.
    • Basic plastic material knowledge.
  • Extensive experience working cross functionally with pharmacist and chemists to find solutions crossing the border between device physics and chemistry and quality compliance.
  • Thorough understanding of injection moulding, its strengths and limitations.
  • Extensive experience working internationally with suppliers including CMOs and test houses including data review.

Key results

  • Decision supportsystem:
    • Device and SW concept, design and verification.
    • Clinical data structure, set up, coordination and analysis.
    • QA responsible.
  • Complex electro-mechanical inhalation drug delivery system:
    • Specification, risk management, system integration, testing, data analysis and design adaptions.
    • Industrial and Man Machine Interfacedesign.
  • Comprehensive revision of mass-produced Primary Packaging.
    • Revision of:
      specifications, design control, quality specifications/agreements, risk management and test methods to comply with user needs, process capability, quality and regulation.
    • Major cost savings achieved.
  • IVD blood testing regarding coagulation.
    • Device design and commercial launch.
    • Several patents granted. Received Danish Design Award.
  • Dosing test method for pen injectors and infusion pumps.
    • Invented test method.
    • Used in ISO 11608 Needle-based injection systems.

Software, Standards & Regulation

  • Software:
    • Excel, experienced user.
    • Minitab, basic user.
  • Standards & Regulation Extensive experience working according to and under:
    • ISO 13485 (Design Control), ISO 14971 (Risk) and related standards.
    • MDR, FDA 21 CFR820.30.

Personal Characteristics

He is systematic, analytic, QA minded and has an innovative and proactive mindset.

He is a perfectionist with an eye for details and correctness, however pragmatic regarding what is needed to achieve objectives.

He has a strong system understanding and of the physics involved.

He meets people with positive expectations and establish respectful, productive and efficient relationships.

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