- Establishing, leading, and further developing the Manufacturing Engineering & External Operations division within an external production environment.
- Responsibility for the industrialization of manufacturing, technology transfer from development to production, and ensuring the market readiness of Class III cardiovascular medical devices.
- Management of activities in the areas of Design for Manufacturability (DFM), Design for Scalability, and technical transfers in close collaboration with Research & Development (R&D) and external manufacturing partners.
- Lead and oversee contract manufacturers and critical suppliers while ensuring process validations (IQ/OQ/PQ), effective production risk controls, sufficient process capability, and scalable manufacturing capacity.
- Establishing governance structures for production, relevant key performance indicators (KPIs), validation strategies, and a systematic supplier management system to ensure quality, compliance, and operational excellence.
- Close collaboration with the Quality Assurance, Regulatory Affairs, Clinical Affairs, and Supply Chain departments to support regulatory approval processes, audits and inspections, CAPA measures, change control, and global commercialization activities.
- Leading strategic and operational improvement initiatives within the external manufacturing network to sustainably enhance the quality, efficiency, scalability, and cost-effectiveness of production.
- Supporting production capacity planning, supplier industrialization, and the development of long-term strategies for scaling manufacturing in alignment with the company’s growth objectives.
Director Manufacturing Engineering & External Operations
Stuttgart
Full-time
Permanent employee
Mission
Profile
- A successfully completed degree in engineering, biomedical engineering, manufacturing engineering, or a related field.
- At least 10 years of professional experience in manufacturing engineering, industrialization, production engineering, or technical operations within the medical technology industry.
- Substantial experience with Class III medical devices, catheter-based technologies, or other complex interventional medical devices.
- At least 3 years ot proven leadership experience in external or outsourced manufacturing structures, particularly in the areas of supplier management, technology transfer, and industrialization and commercialization projects.
- Extensive expertise in process validation (IQ/OQ/PQ), PFMEA, process capability analyses, and risk management for manufacturing processes.
- Very good knowledge of regulatory requirements and quality standards, particularly FDA Design Controls, FDA QSR/QMSR, ISO 13485, ISO 14971, and the European Medical Device Regulation (EU MDR).
- Business-level proficiency in spoken and written German and English.
- Willingness to travel domestically and internationally.
Why us?
- Help shape the future of innovative cardiovascular medical technologies—from industrialization to global market launch.
- Take on a strategically important leadership role with a high degree of autonomy and a lasting impact on the company’s success.
- Work in an international, innovation-driven environment with short decision-making processes and significant creative freedom.
- Benefit from collaboration with a global network of first-class manufacturing and technology partners.
- Look forward to flexible work models, motivated colleagues, modern workspaces, excellent transportation access, and attractive compensation.
Contact
Please submit your complete application materials—including your resume and (employment) references—via our careers page: https://kardion-gmbh.jobs.personio.de/
For this position, please submit your resume and cover letter in English.
We look forward to hearing from you!
For this position, please submit your resume and cover letter in English.
We look forward to hearing from you!
About us
KARDION is an innovative MedTech enterprise based in Stuttgart, Germany and Irvine, California.
In close collaboration with doctors, our team of engineers and human factors experts designs compelling and pioneering medical systems and develops our easy to use and market leading products until market maturity in technical perfection.
Our holistic approach allows us to understand individual user needs, derive technical requirements and make complex product solutions reliable and easy to use.
At the intersection of technology and healthcare, our goal is to enable cardiovascular patients to live a better life and to provide doctors with the best support. With enthusiasm, sincerity and commitment we will take the state of the art in MedTech to the next level.
In close collaboration with doctors, our team of engineers and human factors experts designs compelling and pioneering medical systems and develops our easy to use and market leading products until market maturity in technical perfection.
Our holistic approach allows us to understand individual user needs, derive technical requirements and make complex product solutions reliable and easy to use.
At the intersection of technology and healthcare, our goal is to enable cardiovascular patients to live a better life and to provide doctors with the best support. With enthusiasm, sincerity and commitment we will take the state of the art in MedTech to the next level.