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R&D and Usability

ID1041

R&D Program Management, Usability

MSc, Mechatronics Engineering
Available for: Part-time, full-time, tasks

Contact us for full CV

mf@medicologic.com
(+45) 48 24 51 13

Competences

  • Medical Device Development

    • Program and project management including usability, and clinical trials

    • Syringes, injectors, pumps, IVD and monitoring systems including reagents, surgical instruments, hemostats, wound healing

    • Mechanics, electronics, software and connectivity

    • HFE/UE: formative/summative testing, ISO/IEC 62366

    • Design Control: MDR, ISO 13485, 21 CFR 820.30

    • Risk analysis: ISO 14971, FMEA

    • Root Cause Analysis, datamining and trend spotting,

    • Design Verification Test, Design of Experiments

    • Test methods and measurement uncertainty: ISO 2859, ISO 3951, ISO 17025

    • 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 plastic injection molding, its strengths and limitations

  • Extensive experience working internationally with suppliers including CMOs and test houses.

Key results

  • Program Management:

    • Established consortium of 13 partners, was awarded 7.3 M€ EU funding and led the project from concept to successful clinical validation.

  • Decision support system:

    • Device and SW concept, design and verification

    • Clinical data structure, set up, coordination and analysis

  • Complex electro-mechanical inhalation drug delivery system:

    • Specification, risk management, system integration, testing, data analysis and design adaptions

    • Industrial and Man Machine Interface design

  • 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. Danish Design Award

  • Dosing test method for pen injectors and infusion pumps

    • Invented test method used in ISO 11608-1 Needle-based injection systems for medical use

Software and Standards

Software:

  • SAP, skilled user
  • Veeva Vault, skilled user
  • Excel, experienced user

Standards & Regulation
Extensive experience working according to and under:

  • ISO 13485 (Design Control), ISO 14971 (Risk) and related standards
  • MDR, FDA 21 CFR 820.30

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