Process & Equipment Engineering Manager

Linxens; Mantes-la-Jolie; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

Linxens, a global leader in micro-connectors, is seeking a Senior Equipment Design & Process Engineer to drive manufacturing equipment design, qualification and validation. You will shape projects from concept through IQ/OQ/PQ, collaborating with cross‑functional teams in a regulated environment.

Join Linxens to contribute to prototypes, scale from pilot to production, and support site investment plans while maintaining a strong focus on quality and regulatory compliance.

Qualifications

• 6-10 years of experience in equipment design and process engineering in the medical device industry.
• Masters or Bachelor’s degree in Mechanical or Industrial Engineering 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.

Responsabilités

• Lead the design, tendering, acquisition, installation, and integration of manufacturing equipment.
• Ensure compliance with ISO 13485 and applicable regulatory standards.
• Collaborate with Process Validation Engineer to ensure full qualification and validation of equipment and processes (IQ/OQ/PQ).
• 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.
• Develop and implement prototyping capabilities to support R&D and innovation projects.
• Ensure a smooth transition from prototyping to industrial production.
• Contribute to 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.

Connaissances

Equipment design

Process engineering

Regulated manufacturing

ISO 13485 knowledge

Communication

Stakeholder management

Formation

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

Description du poste

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

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

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
• Develop and implement prototyping capabilities to support R&D and innovation projects
• Ensure a smooth and efficient transition from prototyping to industrial production
• 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 designing & 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

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.