Location: Oberdorf, Switzerland (German or French speaking preferred)
Responsibilities
Lead and support
New Product Introduction (NPI)
activities in a regulated medical device environment
Author and execute
validation protocols (IQ / OQ / PQ)
and ensure compliance with quality standards
Collaborate closely with
R&D, quality, manufacturing, and regulatory teams
Support
design transfer
from development to manufacturing
Drive
CAPA investigations, root cause analysis, and risk management activities
Participate in
PCB design reviews and collaboration with electronics teams (Altium environment)
Ensure compliance with
ISO 13485, MDR, and other regulatory requirements
Contribute to
process improvements and continuous quality initiatives
Qualifications
Strong experience in
Medical Device / MedTech regulatory environments
Hands‑on experience with
validation activities (IQ / OQ / PQ)
Experience with
CAPA, risk management, FMEA, and SPC
Exposure to
ISO 13485 and MDR regulatory frameworks
Experience supporting
design transfer and product industrialization
Knowledge of
PCB development and collaboration using Altium tools
Strong
engineering background
German or French is highly preferred
Experience with
end‑to‑end NPI programs in regulated environments
Proven ability to work in
cross‑functional international teams
If you are interested in learning more, feel free to
apply or reach out directly via LinkedIn .
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