Vollzeit |Schaftenau
Are you an expert in your field and ready to apply your know-how to exciting projects?
As part of the Hamburg-based TECCON Group—with over 450 employees in IT, engineering, and business—we develop innovative solutions for renowned clients. Our mission is to recognize and nurture human potential by creating tailored connections between companies and talent. Contribute your expertise to our projects and help shape the future.
Deine Aufgaben
* Product Development: You support the development of innovative (electro)mechanical medical devices and combination products from concept to market launch.
* Systems Engineering & Specifications: You define requirements, interfaces, and technical specifications, using CAD, FEA, mathematical modeling, and prototyping.
* Design Controls & Verification: You ensure all development activities are documented, tested, and validated, including test strategies, engineering evaluations, and manufacturing processes.
* Technology & Change Management: You perform technology scouting and manage change control processes (e.g., 1QEM, Agile).
* Interface Management (Drug/Device): You define and coordinate interfaces with drug, packaging, labeling, and digital ecosystems.
* Supplier & Partner Management: You support the selection and management of project-specific third parties.
* Lifecycle Management: You oversee products throughout their lifecycle and optimize existing solutions.
* Audit & Compliance: You support internal and external audits related to medical devices and packaging.
* Regulatory Support: You prepare technical documentation for regulatory submissions and respond to health authority queries.
* Professional Development: You take on additional roles and responsibilities through training and project needs.
Dein Profil
* Education & Experience: You hold a degree in Mechanical Engineering, Medical Technology, Mechatronics, or a related field and have several years of experience in medical device or combination product development.
* Engineering Expertise: You are proficient in CAD, FEA, modeling, prototyping, and have strong knowledge of system architectures and manufacturing processes.
* Regulatory Knowledge: You are familiar with international standards and regulations (e.g., ISO 13485, MDR, FDA) and apply them confidently in practice.
* Project & Interface Management: You have experience in cross-functional collaboration and managing internal and external partners.
* Change & Process Management: You are experienced with tools like Agile or 1QEM and structured change management.
* Communication & Documentation: You produce precise technical documentation and communicate clearly with stakeholders, authorities, and project teams.
* Languages & Location: You have excellent English and German skills and are willing to work at least 60% on-site in Schaftenau.
Deine Benefits
* Exciting challenges and responsibilities with room for autonomy.
* Flexible working hours and remote options to balance professional and personal commitments.
* Long-term prospects in a dynamic and dedicated team.
* Diverse opportunities for development and further training.
* Engaging team events that strengthen team spirit and add variety.
Your starting salary will be at least EUR 70,000 gross per year, with the potential for market-competitive overpayment depending on your qualifications and experience.
Ihre Ansprechpartnerin
Renate Stefanowski
renate.-
TECCON Consulting GmbH
Am Tabor 36
1020 Wien