Description

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

Languages

German
Native or bilingual
English
Native or bilingual
French
Native or bilingual
Polish
Basic
Italian
Basic
Spanish
Basic

Workplace preferences

Can work on-site

Zug (up to 50km)

Lemax GmbH,
Senior Consultant
MEDICAL
January 2025 - January 2026 (1 year)
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
January 2023 - January 2025 (2 years)
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
January 2020 - January 2023 (3 years)
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