Linxens
Medical Device
Manager-Equipment&ProcessEngineering
Neural analysis suggests this role is
optimal for Manager candidates.
“Manager - Equipment & Process Engineering at Linxens. Skills: Equipment engineering, Process engineering, Prototyping, Industrialization. Contribute to planning. Define requirements”
Industry & Context.
What They're Looking For.
Must Have
6-10 years experience equipment & process engineering, ISO 13485 knowledge, Regulated manufacturing environments knowledge, Equipment qualification experience, Process validation experience, Fluent in English, Fluent in French
Nice to Have
Masters / Bachelors in Engineer
What You'll Do.
Contribute to planning
Define process design activities
Lead equipment design
Lead equipment tendering
Lead equipment acquisition
Lead equipment installation
Lead equipment integration
Ensure compliance with ISO 13485
Ensure compliance with regulatory standards
Ensure qualification of equipment
Ensure validation of equipment
Ensure qualification of processes
Ensure validation of processes
Develop prototyping capabilities
Implement prototyping capabilities
Ensure transition from prototyping
Ensure transition to industrial production
Contribute to site investment plan
Execute site investment plan
Ensure project follow-up
Ensure budget adherence
Define Make-or-Buy strategies
Execute Make-or-Buy strategies
Evaluate internal manufacturing capabilities
Evaluate external sourcing options
Build strategic partnerships with suppliers
Manage strategic partnerships with suppliers
Build strategic partnerships with subcontractors
Manage strategic partnerships with subcontractors
How You'll Work.
Team & Collaboration
Process Validation Engineer
Process & Methodology
Timeline alignment, Project follow-up, Budget adherence, Prioritization
Full Job Description
**_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 _**Responsibilities**_ _Project Involvement & Timeline Definition_ * 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, a
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