Development Engineer Quality Management | Entwicklungsingenieur Qualitätsmanagement (m/w/d) 1702-158
PAPEVE GmbH Der Spezialist für Ingenieure Techniker und Fachpersonal
Job Summary
This role involves serving as a Development Engineer for Quality Management, focusing on the regulatory support of an innovative product line, specifically high-end laser microscope systems (up to Laser Class 4). Day-to-day tasks include guiding development projects from concept to market launch, ensuring regulatory requirements are met early and practically, and conducting comprehensive risk analyses covering functional, electrical, mechanical, and laser safety. The engineer will be responsible for defining and implementing appropriate protective measures. Collaboration is key, working closely with R&D, Quality, testing labs, and service teams to implement relevant international standards (focusing on IEC 60825-1, IEC 61010-1). A core responsibility is managing the technical documentation for CE conformity and supporting international approvals, including NRTL (USA/Canada) and FDA registrations (CDRH). The ideal candidate holds a degree in Engineering (Mechanical, Electrical, or Optoelectronics) with additional QM training, possesses experience in regulatory project support, and is proficient in both German and English.
Required Skills
Education
Degree in Mechanical Engineering, Electrical Engineering, or Optoelectronics with additional training in Quality Management, or comparable qualification.
Experience
- Experience in the regulatory support of development projects
- Knowledge of complex technical or laser-based systems is ideal
- Professional experience ensuring compliance with international standards and regulatory requirements
Languages
Additional
- Support international approvals including NRTL (USA/Canada) and FDA registrations (CDRH). Optional expertise in IVD products (Class A) and FDA Class 1.
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