Process Design Engineer / Equipment Engineer

Responsibilities

• Project Planning & Timeline Definition
• Participate in early project phases (projects, pre-projects, and exploratory studies) by contributing to project planning, gathering requirements, and defining equipment specifications.
• Define equipment and process design activities, establishing clear engineering tasks aligned with engineering and quality standards to ensure timely project delivery.
• Equipment & Process Design, Installation and Validation
• Lead the design, development, and integration of equipment in compliance with ISO 13485 and applicable regulatory standards.
• Evaluate manufacturing solutions and ensure alignment with product and production requirements.
• Conduct gap analyses (technology, workforce, and capabilities) to ensure successful transfer to production.
• Perform risk analyses and identify critical success factors for equipment and process implementation.
• Prepare engineering requirements, business cases, and CAPEX proposals for new equipment and processes.
• Develop equipment specifications, manage supplier selection, conduct tender evaluations, and support purchase order awards.
• Lead design reviews (internal and external) and manage investment projects using structured project management methodologies.
• Ensure proper qualification and validation activities, including FAT, SAT, IQ, and participation in process validation activities.
• Prototyping & Industrialization Support
• Monitor emerging technologies and equipment developments in the market.
• Develop and implement prototyping capabilities to support R&D and innovation projects.
• Ensure smooth transition from prototyping phases to full industrial production.
• Qualification
• 6 -10 years of experience in Equipment and Process Engineering in the medical device industry
• Masters OR Bachelors in Engineering (Mechanical, Industrial, OR related field)
• Experience in equipment sourcing & qualification, commissioning and documentation
• Know how in process validation (IQ, OQ, PQ) and ISO 13485
• Excellent communication and stakeholder management skills
• Fluent in English
• Join Linxens to work in a multicultural environment, collaborating with leading tech innovators and making a global impact on technology.

Benefits

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

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