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Expleo

End-to-end engineering, tech consulting, quality services

Industrial Process Design

Biomedical Engineering & Medical DevicesPosted on Nov 12
Full-timeRouen, France

About the Job

Requirements

  • A five-year post-secondary qualification in general engineering, process engineering, or production/utilities engineering is required.
  • At least five years of experience with equipment is required.
  • Knowledge of the pharmaceutical sector is strongly preferred.
  • Expertise in design-control processes for injectable combination products, including 21 CFR Part 820 or ISO 13485, is required.
  • Expertise in medical devices, including primary and secondary packaging and their interaction with the medicine, is required.
  • Expertise in validation, quality, or regulatory work on aseptic processes is required.
  • Ability to plan, report on, and track development projects is required.
  • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, and Visio), Microsoft Project, and Teams is required.
  • Written and spoken English is required; English is the department's working language.

Responsibilities

  • Contribute to the technical development of a combination product or medical device through submission and/or transfer.
  • Establish product specifications in collaboration with component suppliers and quality-control laboratories.
  • Create and maintain technical documentation, including Design Control documentation required by applicable quality standards and regulations and documentation submitted to the notified body.
  • Develop test plans, write test protocols, and plan Design Verification test execution, including logistical support, sampling, and test tracking with the GDPU laboratories.
  • Transfer knowledge, methods, and specifications to industrial sites.
  • Deliver work according to the project schedule, coordinate with multidisciplinary and international teams, and report on progress.
  • Create the design portion of the Design History File, including specifications and verification tests.
  • Track and coordinate design-verification and design-analysis characterization tests.
  • Develop products through design-documentation strategy and design-verification testing, applying Design Control under ISO 13485 and 21 CFR Part 820.

Desired Qualifications

  • Knowledge of the pharmaceutical sector is strongly preferred.

About the Company

Expleo

End-to-end engineering, tech consulting, quality services

Expleo provides end-to-end engineering, technology consulting, and quality services to help businesses with digital transformation. It combines software quality assurance and testing with engineering and R&D capabilities to design, build, test, deploy, and maintain software-enabled and engineered systems. It stands out by integrating software quality expertise with broader engineering and digital-transformation offerings under one umbrella for industries like banking and telecommunications. Its goal is to help organizations navigate digital transformation by delivering reliable, efficient, and scalable software and systems.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Montigny-le-Bretonneux, France
Founded
1966

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