Scale up & Industrialization Expert Medical Devices (d/f/m)

Job Description Summary

As Scale up & Industrialization Expert Medical Devices you will be responsible for scale up and industrialization projects of medical devices and device component of combination products, from components moulding to assembly and packaging.

Job Description

Key Responsibilities:

• Lead the industrialization and scale up of medical devices and combination products, including injection moulding, assembling and packaging.

• Overview or support of qualification and validation activities for moulding, assembling and packaging of medical devices and combination products.

• Actively participate in technology and process transfer, including transfer between CMOs, internal sites or between CMOs and internal sites.

• Maintain the technical documentation of assigned platforms, either by direct handling or orientation of other team members, including Risk Management File and Post-Market Surveillance.

• Support all internal and external audits on medical devices and combination products, with presence at the site whenever required, actively participating in the definition and implementation of CAPA plans.

• Support all submission activities to health authorities and Notified Bodies.

• Handle and control the change control process for the assigned activities.

• Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed.

What you will bring to the role:

• Mechanical, Industrial or electronical Engineering (other with relevant background also consider)/ Pharmacy / science / equivalent from a reputed institute.

• Min. 10 years of experience in manufacturing process of medical devices (other relevant experience also considered).

• Experience in design control for medical devices.

• Experience in plastics moulding process or medical devices assembling process (experience in both processes is preferred).

• In-depth GxP knowledge, Quality Risk Management, broad IT knowledge, continuous improvement.

• Fluent in English (written and spoken), excellent communication skills.

• Experience of working in a multicultural self-directed team.

What we offer: 

Job location: Ljubljana.

Contract type: permanent contract with 6-month probation period.

Expected weekly working hours: 40 

*Pay range (annual gross salary): €65,840 – €98,760 EUR

*Salary at Sandoz is based on job level, qualifications, specific skills, and work experience. Fully proficient candidates are usually placed around the market median, less experienced candidates lower in the range, and those with strong or niche expertise higher. When determining placement within the range, we also consider internal pay equity and external market data. 

Our compensation package additionally includes: 

• Annual bonus (STI): percentage of annual salary.

• Vacation allowance: in 2026 it was €2,450.00 net.

• Christmas bonus: in 2025 it was €2,100 gross.

• OurShare: every year, an employee of Lek d.d. will be entitled to receive shares of Sandoz AG.

• Voluntary Additional Pension Scheme: The company fully covers the contribution for your supplementary pension plan, amounting to 5.844% of your gross salary.

• Allowance for shift work (15%); rotational shifts (20%), night shift work (70%), Sunday/public holiday work (50%), overtime work (30%) – if applicable for position.

• Collective life and accident insurance (24/7 coverage).

• A hybrid work environment offering flexibility and remote work possibilities.

Ready for your next career move? 
You are kindly invited to submit your application in English and Slovene, including a CV, by 22.07.2026. 

 

Why Sandoz? 

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have the ambition to do more so that everyone can benefit from the basic human right of good health. 

With investments in new development capabilities, production sites, new acquisitions and partnerships, we have the opportunity to shape a sustainable future for Sandoz and to help even more people gain access to low-cost, high-quality medicines.  

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues who, in return for applying their skills, experience an agile and collegiate environment where diversity of thought is welcomed and where personal growth is supported!  

Join us in helping to make healthcare fairer and faster.  

The future is ours to shape. 

Commitment to Diversity & Inclusion:  

We are committed to building an outstanding, inclusive work environment and to forming diverse teams that are representative of the patients and communities we serve.    

#Sandoz 

#Hybrid

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Kot strokovnjak za prenos v industrijsko proizvodnjo in industrializacijo medicinskih pripomočkov boste odgovorni za vodenje projektov povečanja obsega proizvodnje in industrializacije medicinskih pripomočkov ter komponent kombiniranih izdelkov, od izdelave komponent z brizganjem do njihove sestave in pakiranja.

Skills Desired