Location: Oberdorf, Switzerland (German or French speaking preferred)
We are looking for an experienced Engineering professional to join an innovative team working on medical device development and product industrialization within a highly regulated environment.
This role is ideal for someone with strong experience in New Product Introduction (NPI), validation activities, and regulatory compliance in the MedTech industry .
Responsibilities and Qualifications
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
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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