Technical Project Management

Extensive experience in the management of major technical projects in medical technology, with responsibility for development, line automation, quality, logistics and GMP-compliant implementation of several product lines

Responsible for the setup, relocation and qualification (IQ/OQ/PQ) of eight automated production lines in a clean room (ISO 8), including CE certifications, validation documentation and commissioning

Proven experience in the regulatory environment, in particular in dealing with ISO 13485 and IVD-R

Technically very broad-based, with in-depth expertise in automation, plastics technology, line integration, test cell development, injection molding tools and inline-capable processes for high-volume production

Overall project manager and management of a team in the following areas: development, quality, plastics production, automation, purchasing, sampling, logistics

Development projects across the entire product development process through to the implementation of the

Realization of line automation for the production of products with GMP elements

Automation project manager: planning of the entire automation lines for the production of new plastic products (ISO8 clean room) incl. 4 - 8 synchronized injection moulding machines

Design of the products and graphic creation of the colored product graphics

Automated changeover of various product derivatives within the lines

Partial and full CE certification of the automation lines in various projects

Relocation of eight fully automated production lines including step-by-step commissioning

Conception and procurement of various injection molding machines and integration into the overall automation including negotiation of alignment, coordination of cycle times, qualification, etc.

Coordination of the development of injection molds (multiple cavities and various plastics) and - plastics) and integration into the overall project planning

Managing the relocation of five additional fully automated production lines including various clean room conversions and coordinating twelve suppliers involved in the relocation

Conversion of existing automation lines into new projects, including qualification of the systems and installed measuring equipment, management of commissioning, product validation processes and line validations (IQ, OQ and PQ)

Coordination of the development of automated packaging stations integrated into the lines

Implementation of a functioning product traceability process with UV-based QR codes for automatically assembled product lines (Industry 4.0)

International supplier management / coordination as OEM

Cooperation with suppliers to develop automated test cell for leakage measurements of products and integration into existing line

Project roadmaps, product responsibility, budget responsibility, scheduling, run-in and run-out

and phase-out controls in current series, reporting to management

Specifications, LOPs, REKOs, RfQs, FMEAs, tracking of test laboratories

Project management for the discontinuation of a component (display module) in a series product

Coordination of an interdisciplinary team (hardware, electronics, validation)

Planning and implementation of necessary validations incl. test laboratory management

Change management in the international supplier network

Budget and deadline responsibility, reporting to management

Project management as OEM

Management of a team of 28 people in the areas of software, hardware, electronics, validation

(Research & Development)

Various projects in the Product Care / R&D area (national and international)

Interface responsibility between the departments

International supplier management of various suppliers

Introduction of a team structure (departmental structuring)

Interface between development, quality, regulatory, purchasing, production and documentation

Budget planning and capacity planning Annual scope

Development of a project roadmap for critical projects

Support for SAP / ECR implementation

Certification with UL and Intertec

CE certification processes during ongoing series production