Manager - Equipment & Process Engineering

LINXENS Holding; Mantes-la-Jolie; On-site; EUR 75,000 - 100,000; Full time

Job summary

Linxens in Île-de-France seeks a Senior Equipment & Process Engineer to drive design, qualification, and validation of manufacturing equipment in the medical device sector. You will lead early project phases, align with regulatory and ISO 13485 standards, and ensure robust IQ/OQ/PQ workflows while collaborating with engineering, quality, and procurement teams.

Fluency in English and French is required, plus 6–10 years of relevant experience.

Qualifications

• 6–10 years of experience in equipment & process engineering within the medical device industry.
• Masters or Bachelors in Engineering (Mechanical, Industrial or related field).
• Fluent in English and French.

Responsibilities

• Participate in early project phases (pre-projects, feasibility studies, explorations) with planning and timeline alignment.
• Define and structure process design activities aligned with engineering, quality, and regulatory requirements.
• Lead equipment design, qualification, validation, and installation with IQ/OQ/PQ under ISO 13485 compliance.
• Develop prototyping capabilities and support transitions from prototyping to industrial production.
• Contribute to site investment planning and make-or-buy strategy with suppliers and internal capabilities.

Skills

English & French

Communication

Stakeholder management

Education

Master's / Bachelor's in Engineering

Tools

IQ/OQ/PQ

ISO 13485

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, 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

Qualifications

• 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 1345 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 lawf.

At Linxens, employees are at the heart of the Group’s strategic objectives. Linxens teams are made of highly-skilled professionals who wish to surpass themselves in a result-oriented environment dedicated to meeting the needs of clients. Our people are fully committed to the growth and performance of the Group as well as with their team. In this demanding and friendly work environment, they develop both personally and professionally.

40 years of history, join us to write the next pages!