4 beste Stellen als process engineer in geneva ge – aktuell auf Personalsuche

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Process Validation Engineer - Additive Manufacturing

Spineart -
Plan-les-Ouates, GE

Direkt bewerben

Details zur Stelle

Festanstellung | 100%
vor 21 Stunden

Qualifikationen

Französisch
Englisch
Produktion
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

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

Direkt bewerben

Erweiterte Suche

process engineer Jobs in geneva ge

Process Validation Engineer - Additive Manufacturing

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