Process Development Engineer Medical Devices (m/f/d)

Heraeus Holding GmbH; Dresden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Heraeus Holding GmbH in Dresden sucht einen Process Development Engineer im Bereich Medical Devices zur Entwicklung und Optimierung von Herstellungsprozessen. Sie arbeiten eng mit Produktrealisierungsteams zusammen und begleiten Transfers von Entwicklung zu Serienproduktion.

Sie verfügen über ein Ingenieurstudium oder Ausbildung, 3–5 Jahre relevante Erfahrung, solide Kenntnisse in Prozessentwicklung, Validierung und Statistik sowie Deutsch- und Englischkenntnisse.

Qualifications

• Abgeschlossenes Studium im Ingenieurwesen oder abgeschlossene Berufsausbildung mit relevanter Erfahrung.
• Mindestens 3–5 Jahre Berufserfahrung im medizinischen Bereich oder vergleichbar regulierten Umfeld.
• Gute Kenntnisse in Prozessentwicklung, Prozessvalidierung und Statistik.
• Erfahrung mit Produkt-Ramp-ups und Transferprogrammen.
• Erfahrung in der Serienfertigung, Ursachenanalyse und Qualitätsuntersuchungen.
• Gute Deutsch- und Englischkenntnisse in Wort und Schrift.

Responsibilities

• Entwicklung und Optimierung von Fertigungsprozessen für bestehende und neue Produkte.
• Durchführung von Prozesscharakterisierung, -validierung und Dokumentation.
• Unterstützung bei der Einführung neuer Technologien im Prozessingenieurwesen.
• Begleitung des Transfers neuer Produkte von der Entwicklung zur Serienfertigung.
• Sicherstellung der Prozessqualität entlang des Produktlebenszyklus.

Skills

Process development

Process validation

Statistics

Transfer programs

Root cause analysis

Team player

Education

Engineering degree

Tools

Change control systems

Job description

Process Development Engineer Medical Devices (m/f/d)

Permanent

About Heraeus

Making displays foldable? Help hearts beat with micro-particles? Work on solutions involving precious metals? As a family-owned global technology group we help our customers to always being one step ahead. Whether production, research, sales or administration - we love being the invisible force behind innovation. We deliver world-class quality in the areas of Precious Metals, Healthcare, Semiconductor & Electronics and Industrials. As one of the top 10 family-owned companies in Germany, we employ around 15,100 employees in 40 countries.

The following challenges await you:

• Within our international engineering team, you will be responsible for the development and optimization of manufacturing processes for existing, as well as novel products, working closely with the relevant product realization teams.
• You will carry out and document process characterizations and process validations independently.
• You have a passion for the quality of the products you are responsible for and support processes throughout the lifecycle of the products.
• You analyze quality factors based on statistical parameters.
• You support the specification and implementation of new technologies in the company as part of the process engineering team.
• You will accompany the transfer of new products from development status to serial manufacturing between development and operations sites.

Your profile:

• You successfully completed a vocational training or an engineering degree and obtained professional experience in the field of plastics and process engineering, catheter manufacturing technologies or plastics processing in serial manufacturing environments.
• Minimum 3-5 years of relevant professional experience in the field of medical technology or in a similarly regulated environment desirable.
• Good understanding of process development, process validation and statistics.
• Experience with product ramp-ups and transfer programs.
• Solid experience in maintaining serial production lines (root cause analysis, quality investigations).
• You are a committed, flexible and motivated team player.
• Communication in German and English (verbally as well as in writing) round up your profile.
• The use of standard IT tools and change control systems is natural for you.