Senior Equipment & Process Engineering Lead

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

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.