Participate in early project phases (pre-projects, feasibility studies, explorations) by contributing to planning, requirement definition, and timeline alignment
Define and structure process design activities aligned with engineering, quality, and regulatory requirements
Equipment & Process Design, Qualification, and Validation
Lead the design, tendering, acquisition, installation, and integration of manufacturing equipment
Ensure compliance with ISO 13485 and applicable regulatory standards
In collaboration with the Process Validation Engineer, ensure full qualification and validation of equipment and processes (IQ/OQ/PQ), ensuring robustness and traceability
Prototyping & Industrialization
Develop and implement prototyping capabilities to support R&D and innovation projects
Ensure a smooth and efficient transition from prototyping to industrial production
Site Investment & Make-or-Buy Strategy
Contribute to the definition and execution of the annual site investment plan aligned with Business Unit strategy
Ensure project follow-up, budget adherence, and prioritization based on industrial and financial objectives
Define and execute Make-or-Buy strategies by evaluating internal manufacturing capabilities and external sourcing options
Build and manage strategic partnerships with suppliers and subcontractors
Qualitifications
6-10 years of experience in equipment & process engineering within the medical device industry
Masters / Bachelors in Engineer (Mechanical, Industrial or related field)
Solid knowledge of ISO 13485 and regulated manufacturing environments
Experience in equipment qualification (IQ/OQ/PQ) and process validation
Strong communication and stakeholder management skills
Fluent in English & French
Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.
Benefits
Health insurance
Additional Information
About Linxens
Linxens is a global leader in micro-connectors, module packaging, antennas & inlays, and secure ID solutions, with over 40 years of innovation. Headquartered in Paris, France, we operate R&D centers and production sites across Germany, France, Sweden, China, India, Singapore and Thailand.
Our solutions serve industries such as telecommunications, finance, transportation, hospitality, e-government, healthcare, and the Internet of Things (IoT).
Our employees' expertise and know-how allow us to continually reinvent ourselves and meet our customers' evolving needs, helping them grow and innovate. Therefore, we invest in developing our employees' skills and career growth.
Working for Linxens means investing in your future. Our growth is creating great opportunities!
Below is the job description for open position
Onelinxens · Mantes