ID1041
R&D Program Management, Usability
MSc, Mechatronics Engineering
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
- Medical Device Development
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Program and project management including usability, and clinical trials
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Syringes, injectors, pumps, IVD and monitoring systems including reagents, surgical instruments, hemostats, wound healing
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Mechanics, electronics, software and connectivity
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HFE/UE: formative/summative testing, ISO/IEC 62366
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Design Control: MDR, ISO 13485, 21 CFR 820.30
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Risk analysis: ISO 14971, FMEA
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Root Cause Analysis, datamining and trend spotting,
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Design Verification Test, Design of Experiments
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Test methods and measurement uncertainty: ISO 2859, ISO 3951, ISO 17025
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Plastic material knowledge
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Extensive experience working cross functionally with pharmacist and chemists to find solutions crossing the border between device physics and chemistry and quality compliance.
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Thorough understanding of plastic injection molding, its strengths and limitations
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Extensive experience working internationally with suppliers including CMOs and test houses.
Key results
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Program Management:
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Established consortium of 13 partners, was awarded 7.3 M€ EU funding and led the project from concept to successful clinical validation.
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Decision support system:
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Device and SW concept, design and verification
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Clinical data structure, set up, coordination and analysis
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Complex electro-mechanical inhalation drug delivery system:
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Specification, risk management, system integration, testing, data analysis and design adaptions
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Industrial and Man Machine Interface design
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Comprehensive revision of mass-produced Primary Packaging
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Revision of specifications, design control, quality specifications/agreements, risk management and test methods to comply with user needs, process capability, quality and regulation.
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Major cost savings achieved
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IVD blood testing regarding coagulation
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Device design and commercial launch. Danish Design Award
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Dosing test method for pen injectors and infusion pumps
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Invented test method used in ISO 11608-1 Needle-based injection systems for medical use
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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