Beschreibung

Senior MedTech executive with 25+ years of experience developing, industrializing, and scaling Class III active implantable medical devices from concept through regulatory approval and commercial production.

Former VP Manufacturing, Manufacturing Director, Head of R&D and Program Director with a proven track record. Leading global teams, establishing ISO 13485-compliant manufacturing systems, managing supplier ecosystems, and delivering successful FDA PMA and CE-marked products.

Experienced advisor to organizations facing critical transition points:

• Prototype → industrialized product

• Engineering → regulated manufacturing

• Clinical success → commercial launch

• Startup technology → investable company

Sprachen

Deutsch
Muttersprachlich oder zweisprachig
Englisch
Muttersprachlich oder zweisprachig
Französisch
Muttersprachlich oder zweisprachig
Polnisch
Grundkenntnisse
Italienisch
Grundkenntnisse
Spanisch
Grundkenntnisse

Arbeitsortpräferenzen

Vor Ort möglich

Zug (bis zu 50 km)

Lemax GmbH,
Senior Consultant
MEDIZIN
Januar 2025 - Januar 2026 (1 Jahr)
Steinhausen, ZG, Switzerland
Advisor Expertise
MedTech Industrialization & Operations
Manufacturing strategy and scale-up planning
Design transfer and production readiness
DFM optimization
Contract manufacturing strategy
Supplier qualification and management
Manufacturing risk assessment
Regulatory & Quality Strategy
FDA PMA pathway experience
CE marking and MDR transition
ISO 13485 quality systems
Design controls and DHF remediation
CAPA and regulatory inspection readiness
Risk management (ISO 14971)
Investor & Board Support
Technical due diligence for investors
Manufacturing readiness assessments
Regulatory risk evaluation
Portfolio company operational support
Interim executive leadership
Board advisory roles
Leadership & Transformation

Building global engineering and manufacturing organizations
Leading cross-functional R&D, Operations, Quality, and Regulatory teams
Managing complex technology transfers
Driving operational excellence
Manufacturing scale-up Supplier Management ISO 13485 Industrialisation Start-up
Cairdac SA,
VP of Manufacturing
Januar 2023 - Januar 2025 (2 Jahre)
Antony, France
•  ISO 13485 QMS setup for manufacturing activity
•  Manufacturing strategy consolidation for FIH and FDA submission
•  Device currently in the FDA submission process
Sequana Medical NV,
VP of Manufacturing
Januar 2020 - Januar 2023 (3 Jahre)
Zurich, Switzerland
•  Managing manufacturing team
•  PMA submission for US market launch
•  Life cycle management and Corrective Action implementation in close cooperation with Engineering, QA and RA
•  Adapt design specifications and processes for continuous yield increase
•  Managing supply chain and distribution centers in US and Europe
•  Introducing and training new employee from all departments