Interim Project Lead

• Over 15 years of experience as project manager in medical device (e.g. surgical devices) & IVD

• Not only certified ISO 13485 lead auditor but also IPMA/GPM certificate project management associate (level D)

• Strong communicator to team members as well as function leaders in cross cultural environments

• Already placed via K-Recruiting with excellent client feedback (2022-2024)

• Leading a x-functional team responsible for budget

• Reporting to upper management

• Directing 2 sub-project leaders

• Continuous alignment with surrounding workflow projects/products

• Problem solving / trouble shooting

• Hiring (temporary) co-workers

• Initiator for clinical study conducted in US

• Planning of a usability validation study

• 7 product development projects (IVD assays & accompanying products)

• 1 product maintenance project (new regulatory requirements on emerging market)

• Various global access projects in various regions: LATAM, NA, APJ

• Initiator/co-initiator of 2 major process improvement projects: Process improvement late product configuration: improved compliance and efficiency; up to 70% cost reduction compared to former process, Lead of a dedicated PPI (= practical process improvement) work group for design control, Strong interaction with various function leaders (VP level)

• Contribution to improvement initiative for PMO

• Improved creation of business cases for strategic re-alignment of project portfolio

• Project planning: work packages; timeline; resources etc.

• Identify & address relevant key-areas: Revise product portfolio, Define necessary activities to meet regulatory requirements (R&D), Define requirements for aligned/harmonized processes to enable cross-site collaboration, Strategy work-shop: present developed strategy to involved stakeholders, Handle-over project to new site, Lead creation of clinical evaluation report required for re-certification

• Take over project lead; re-gain control over project

• Develop & implement “radical approach”

• Respond to issues and provide path forward

• Lead x-functional team in Germany and four US locations

• Identify bottle-necks and implement sustainable improvements

• Temporarily take over 2 additional projects until new project managers have been hired; coach new pms for the first 6 months

• Plan and lead all activities to enable a successful 510(k) submission

Results:

• Re-organisation of entire project

• Recovered 11 months of initial delay

• Decreased cost by >15%

• Developed strategy for FDA inspection together with GM department

• Developed several strategy improvements & guidelines as template for other (future) projects

• Addressed numerous company-wide gaps & inefficiencies: I received the opportunity to present my observations and proposals for sustainable efficiency and strategic improvements to members of the managing board