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Life Science Progress

Life Science Progress

Steen Guldager Petersen

Effective certified project manager who ensures product and progress according to plan and stakeholder expectations. Innovative with ability to keep things simple and to inspire people. More than 12 years experience from both the medical device and the life science industry

Hovedkompetencer

  • Design control & medical devices according to ISO 13485 and 21 CFR 820.
  • Project management, Prince2 certification and more project management courses.
  • Design verification, production transfer and product and process validation including repeatability and reproducibility using statistical methods.
  • Risk management (project and process FMEA) according to ISO 14971.
  • Molecular and cellular biology, biochemistry, immobilization, surface modification and assay technology.
  • Planning and construction of laboratory facilities.
  • Approval for purchase, handling and disposal of radioactive nuclides.

Kontaktinfo

Telefon nr.
40318450
E-mail
Steen.CPH@gmail.com
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Udvalgte projekter og opgaver

Projekterne

Development of IVD class III medical device

Kunde: Medical device manufacturer

Aktiviteter:

Design control and project management from early phase to final product.

Requirements, development, risk management, design reviews, IFU, design verification,

production transfer and validation (based on statistical methods).

Medical device – drug combination product

Kunde: Medical device manufacturer

Aktiviteter:

Verification of product requirements.

Product validation report.

Assessment of device parts for biological / toxicological testing.

 

Development of columns for bio-pharmaceutical purification

Kunde: Biotec-Pharmaceutical manufacturer

Aktiviteter:

Project management and design control from early phase to final product.

Requirements, risk management, design reviews, IFU, production transfer.

Biological and toxicological testing and design validation.

Medical device, QA department:

Kunde: Medical device manufacturer

Aktiviteter:

Definition of upper management responsibility in accordance with ISO 13485.

Assessment of open CAPA’s including re-classification, merge and closure.

Steering document for process validation master plans.

Medical device – Micro catheter for intravascular drug delivery

Kunde: Medical device manufacturer

Aktiviteter:

Project management and design control from early phase to prototype.

Requirements, development and risk management.

Development, QA and launch of SpotOn™ DNA Micro Array Slides

Kunde: Medical device manufacturer

Aktiviteter:

Product management, requirements and IFU.

Growth of human cells and development of non fouling surfaces.

Planning and construction steering of several laboratories.

Department leader
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