Manager - Equipment & Process Engineering

Linxens Group; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Linxens Group in Paris is seeking a Manager for Equipment & Process Engineering. Responsible for leading equipment design and ensuring compliance with ISO 13485 standards, this role requires 6-10 years of experience in the medical device industry.

The ideal candidate will have a Master's or Bachelor's degree in Engineering and possess strong communication and stakeholder management skills. Fluency in English and French is necessary.

Qualifications

• 6-10 years of experience in equipment & process engineering within the medical device industry.
• Solid knowledge of ISO 13485 and regulated manufacturing environments.

Responsabilités

• Participate in early project phases by contributing to planning and timeline alignment.
• Lead the design, acquisition, installation, and integration of manufacturing equipment.
• Ensure compliance with ISO 13485 and ensure full qualification of equipment.

Connaissances

Equipment qualification (IQ/OQ/PQ)

Process validation

Strong communication skills

Stakeholder management

Fluency in English

Fluency in French

Formation

Master's/Bachelor's in Engineering (Mechanical, Industrial or related field)

Description du poste

## Manager - Equipment & Process EngineeringApplylocations: Mantestime type: Full timeposted on: Posted 7 Days Agojob requisition id: JR100900**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 requirementsEquipment & 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 traceabilityPrototyping & Industrialization* Develop and implement prototyping capabilities to support R&D and innovation projects* Ensure a smooth and efficient transition from prototyping to industrial productionSite 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.*LINXENS is an equal-opportunity employer that strictly prohibits unlawful or unethical discrimination. Moreover, as part of our CSR Vitality program, we have committed to recruit, hire, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity, national origin, age, mental/physical disability, marital status, or any other characteristic protected by law.