Medical Device Manufacturing Engineer - Project Lead - Direct Product Marking

Discipline: Quality Assurance
Job type: Permanent
Salary: £Competitive Salary - Depending on experience
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 21917
Published: about 1 month ago
Expiry date: 01 August 2021

Location: Grenoble, France

My client are seeking Quality/Manufacturing Engineers with proven background in the Medical Device industry to join their European team. This role could be based in Grenoble, is open to both permanent employees or contractors.

Reporting to the Orthopedic Manager, this role requires collaboration with internal teams and will be embedded on site with the external client.

Position Requirements:

  • Leading the team regarding Medical Device Manufacturing Engineer- Direct Product Marking (DPM) conversions

  • Support as Manufacturing Engineer which includes.

    • Executing local QMS requirement

    • Document creation / approval

    • FAI preparation

    • NC/CAPA support

    • Managing Work in Progress

    • Product/Process assessment etc.

    • Support of Operations

  • Interact with cross-functional team.

  • Organizing DPM activities:

    • Print approvals.

    • Laser engraving program updates

    • Printing on the part is also included.

    • FAIs & BOM Updates

    • WIP Management / Quality Gate Strategy

    • Liaising with Supplier workstream to involve affected suppliers in the activities above.

  • Reporting out on the status (internal and external manufacturing)

Qualification and Skills:

    • Engineering/Science license and 6 to 8 years work experience in Medical device industry

    • Engineering diploma (diplôme d'ingénieur) with 8 to 10 years of experience in Medical device industry

  • Medical Device packaging and labelling experience is essential.

  • Knowledge on supplier management and Process validation is essential.

  • Working experience on UDI implementation (Class 1r products)

  • Knowledge of ISO 13485/ EU MDR / 21 CFR part 820/ requirements desirable

  • Excellent communication skills and attention to detail.

  • Have a good understanding of engineering and Quality concepts.

  • Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

  • Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

  • Lean Six Sigma training a distinct advantage.

  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).

  • Thorough knowledge and understanding of International Medical Device Regulations

  • Highly developed problem solving and strong analytical skills.

  • Team managing and multisite co-ordination.

  • Proficient in English and French

Existing Right-To-Work in the EU is essential for this role, as sponsorship sadly cannot be considered.

Please apply with your CV or contact katie.dunbar@rbwconsulting.com or +441273 952176 to find out more.

Competitive Salary - Depending on experience