Process Validation Engineer - Additive Manufacturing

• Are you a highly skilled Engineer who is dreaming of a job with a real impact on patients ’lives?
• Do you want to work for an innovative specialist spinal implant company and play a crucial role in ensuring efficiency of our manufacturing processes?
• If yes, come to join our Process Validation team

(Additive Manufacturing)

Together we can shape the future of the healthcare.

As Process Validation Engineer you will participate to the qualification-validation strategy for the processes and activities for which you are responsible (internally and externally).

You will work in close collaboration with R&D, Operations and RA departments and with sub-contractors to qualify their processes.

Your main responsibilities will be

• As Subject Matter Expert (SME) in Additive Manufacturing for Medical Devices
• Managing and monitoring Additive Manufacturing qualification activities, including environmental monitoring and requalification.
• Coordinating/executing validation activities (IQ/OQ/PQ) for equipment, utilities, and cleanroom systems.
• Leading investigations, root cause analysis, CAPA, and non-conformity resolution linked with clean room environment
• Ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820, EU MDR 2017/745, and internal quality systems.
• Analysing quality metrics and identifying opportunities for continuous improvement.
• Creating, Reviewing and approving quality documentation, SOPs, protocols, and reports.
• Interacting with auditors
• Collaborating with Production, Engineering, Regulatory Affairs, and suppliers
• As a key contributor to the quality roadmap across the product development lifecycle:
• Participating to DHF completeness
• Defining, Planning , executing and reviewing all validation/verification activities
• Managing all changes including impact assessment

Your profile

• Proven experience in Validation and Qualification processes, with demonstrated use of ISO 13485, ISO 14971, 21 CFR Part 820, and EU MDR 2017/745
• Minimum of 3 years’ experience in additive manufacturing using metallic materials
• Experience in orthopaedics and/or spinal medical device development is a strong advantage
• Higher education degree in Engineering, preferably Mechanical Engineering
• Ability to work effectively in English ; native or near-native level of French
• Strong communication skills, with the ability to clearly convey technical information to diverse audiences and explain complex regulatory requirements in simple terms
• Excellent technical writing skills, including structured documentation such as protocols, reports, and audit-ready records
• Ability to manage multiple projects and validation activities under tight deadlines
• Ability to challenge decisions that may impact patient safety or regulatory compliance
• Strong problem-solving skills with a pragmatic and solution-oriented approach
• Valid driving licence