Impactful Additive Manufacturing Validation Engineer

Spineart; 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

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.