SPINEART is a privately held medical device company based in Geneva, Switzerland, focused on simplifying the surgical act by designing, developing, and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients.
Selling in over 60 countries, Spineart is a pioneer in its field, having introduced unique technologies in the fields of Minimally Invasive Surgery, Motion Preservation, Fusion, Biologics and Fracture Treatment.
Spineart markets a complete portfolio combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.
Our success also depends on our team’s value. The human being is at the centre of our concerns. We pay special attention to our recruitment to make Spineart a great place to work.
For us, soft skills are as important as hard skills. What we expect from our employees is nothing short of real team spirit, mutual assistance, and self-transcendence.
Our philosophy: Quality, Innovation, Simplicity
Our values: Respect, Integrity, Solution oriented
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:
o 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
We look forward to receiving your application at
https://spineart.bamboohr.com/careers/109?source=aWQ9MTE%3D
Please note that only applications submitted through this link will be reviewed.
Work Location: Hybrid remote in 1228 Plan-les-Ouates, GE
