PRODUCT MANAGER / CLINICAL VALIDATION ENGINEER (MMS) (F/M/D)

We develop, manufacture and market innovative, high-quality medical devices in the field of in vitro diagnostics. Our systems are tailored to professional applications in hospitals, out-patient clinics and medical laboratories.

Our interdisciplinary teams are highly motivated and built on a broad range of technical expertise. We have a strong technical foundation in mechatronics, mechanical and electrical engineering, as well as in various scientific fields such as chemistry, physics, mathematics, life sciences and biomedical analytics. Additionally, our team excels in software and firmware development.

We are always looking for committed and innovative people who want to grow with us.

What we offer?

• Engaging and challenging roles with significant personal responsibility and room for professional growth within a dynamic, highly skilled team with currently ca. 85 colleagues
• Collaborative work environment with a flat hierarchy, embracing agile principles for product development
• Culture of appreciation and responsible collaboration
• Flexible working hours based on trust in a flextime model
• Conveniently located near public transport with dining options in the vicinity
• Bike leasing to our employees (Jobrad)

When you apply, please send us your CV, a motivation letter and relevant certificates.

For positions at MEON Medical Solutions (MMS), please forward applications to:

job@meon-medical.com

For positions at MEON Functional Diagnostics (MFD), please forward applications to:

• Establish procedures for performance evaluation & design validation studies according to relevant regulations (e.g. IVDR), standards (e.g. ISO 13485) and guidelines (e.g. CLSI)
• Coordinate with external partners to ensure compliance of clinical evaluations with certification/registration requirements (e.g. notified body)
• Plan (time, content, resources) and perform activities associated with in-house design validation and clinical performance studies
• Manage documentation (e.g. templates, documentation framework) and prepare submission performance study data
• Review literature for inclusion in validation and post-market surveillance procedures
• Validate tools used in design validation & performance evaluation activities
• Coordinate multi-site evaluation of IVD product & first customer evaluations in Europe
• Create customer information, training material and package inserts for IVD products

• Dynamic, customer-oriented and hands-on personality
• Professional experience (2+ years) in a similar role in the IVD industry or clinical laboratory
• Professional proficiency in German and English (written)
• Strong documentation, organizational and communication skills
• Independent, structured & regulatory-focused way of working combined with management competencies

• University degree (technical university / university of applied science ) in biomedical engineering/science or similar field

• The monthly salary depends on your qualification and professional experience and will in any case be above the collectively agreed minimum salary e.g. € 3 592.61 gross * 14 (38.5 hours, 2 years of experience)