More than 25 years of experience in international project management in the life science and medical technology environment, with a focus on product development, design transfer and manufacturing optimization
Participation in the development of complex medical devices, in particular for ophthalmological applications, including documentation, validation (IQ/OQ/PQ), prototyping and series transfer
Assumption of operational responsibility for production relocations and the realignment of manufacturing processes in regulated environments (e.g. clean room ISO 7, ISO 13485, FDA/GMP)
Experienced in the technical coordination of interdisciplinary teams from development, quality assurance, production and IT - even under high complexity and time pressure
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Study of law
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Technical Project Management, Project Management, Team Management, Production Processes, Project Controlling, Design Transfer, MDR / ISO 13485 / FDA / GMP, MedTech
Key-Facts
Extract from Previous Activities
Medical Device Company
Project Manager Medical Devices
Project manager for the development of a medical device for eye surgery with laser technology
Introduction of a new QMS system in accordance with the new MDR regulations
Definition of SOPs in accordance with the new MDR guidelines
Creation of new templates for the QMS system
Overall project management including project, budget and resource planning
Ensuring compliance with customer and regulatory requirements
Part of product development:
Requirements management (with customers, sales organizations, market analysis)
Design review (with external suppliers)
Regulatory affairs
Clinical evaluation
Risk management
Quality management (initial sample tests, documentation)
System validation / verification
Technical documentation
Prototyping
Design transfer to production
Procurement of new suppliers
Clean room qualification (class ISO 7)
Sealing seam qualification/validation of the packaging
Production transfer/design transfer
New development of production processes
Quality management (initial sample tests, biocompatibility, LAL, chemical analysis, incoming goods inspection...)
Pharmaceutical Company
Project Manager Pharma
Project management of the product incl. technology (electrical & mechanical), validation, verification
Requirements management: collection and evaluation of customer requirements, transfer of the requirements to the HPALM system and evaluation with the technology
Implementation of the documentation, qualification of the machines
FAT, SAT and commissioning at the customer's site
Responsible for milestone tracking, budget control and reporting to senior management
Production relocation/design transfer
Medical Device Company
Project Manager Medical Devices
Responsible for the development, construction and design of a medical device
Creation of a project plan, document management, coordination and recording of regular project meetings, budget control, risk management
Team coordination (hardware development team, regulatory affairs, IT/software, packaging...)
The design of the medical device included the consolidation of different technologies and devices (middleware, handheld, benchtop, management software), also their data exchange, communication and remote control of the device
Requirements management including field research at customer sites (worldwide) and coordination of customer requirements with the project team
Feasibility study of customer requirements