Process Validation Engineer – Additive Manufacturing

Jobtailor; Plan-les-Ouates; Vor Ort; CHF 85.000 - 115.000; Vollzeit

Zusammenfassung

Spineart is seeking a highly skilled Process Validation Engineer to join their team in Switzerland. This role will impact patient lives through ensuring the efficiency of manufacturing processes in spinal implants. Key responsibilities include managing qualification activities, coordinating validation processes, and ensuring compliance with critical regulations. Candidates should have a higher education degree in Engineering, with at least 3 years of additive manufacturing experience and fluency in both English and French.

Qualifikationen

• Proven experience in validation/qualification processes.
• Minimum of 3 years’ experience in additive manufacturing using metallic materials.
• Experience in orthopaedics/spinal medical device development is a strong advantage.
• Ability to work effectively in English and near-native French.

Aufgaben

• Manage and monitor Additive Manufacturing qualification activities.
• Coordinate/execute validation activities for equipment and cleanroom systems.
• Lead investigations and root cause analysis related to cleanroom environment.
• Ensure compliance with regulatory standards and quality systems.
• Analyze quality metrics and identify opportunities for improvement.

Kenntnisse

Validation and Qualification processes

Additive Manufacturing

ISO 13485

ISO 14971

21 CFR Part 820

EU MDR 2017/745

Technical writing

Problem-solving

Ausbildung

Higher education degree in Engineering (Mechanical Engineering preferred)

Jobbeschreibung

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