ID1055
Senior Project Manager
MSc Mechanical Engineering, DTU
Available for: Part-time, full-time, tasks
Contact us for full CV
Competences
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Project Management of international cross technology projects involving:
Mechanics, electronics, software and connectivity.
Electromechanical drug delivery, diagnostic and monitoring systems including reagents.
Drug Delivery, drug/device combinations, surgical devices and IVD, also involving clinical trials.
Inhalation, injection, infusion, jet-injection and transdermal drug delivery technologies. -
Design Control: MDR, ISO 13485, 21 CFR 820.30
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Medical Device R&D development processes: design and implementation
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Product oriented ideation, concept generation and patenting
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Human Factor Engineering including field studies and research
Key results
- Successfully managed an international project with 13 partners and 50+ persons directly involved. Resulting in convincing clinical outcome.
- Project management of the complex electro-mechanical drug delivery system for inhalation of insulin: system integration and industrial and Man Machine Interface design.
- Project Management of comprehensive revision of specifications regarding all insulin vials and cartridges. Substantial cost reductions achieved.
- Project management of coagulation diagnostic and monitoring IVD device: development and commercial launch. Several patents granted. Received Danish Design Award.
- Development of compliant Device Development Manual.
- Development of successful Technology Research process.
Software, Standards & Regulation
Software
- MS Office, SharePoint, Projects: experienced user
- Adobe Acrobat Pro: experienced user
Standards & Regulation
- Extensive experience working according to and under:
ISO 13485 (Design Control), ISO 14971 (Risk) and related standards
MDR and FDA 21 CFR 820.30 regulation
Personal Characteristics
He is an experienced and quality minded Senior Project Manager, through all stages of Medical Device R&D, from concept to late-stage development and launch.
He has an innovative mindset, resulting in more than 30 patent families and a strong understanding of patent work.
He is fast adapting to change, proactive and analytic, sees opportunities, thrive coaching the team, getting things organised and persistently continue till the job is done.
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