Risk Management & Design Control Specialist (m/f/d) Medical Devices

Vollzeit | Kufstein

Are you an expert in your field, ready to apply your know-how to exciting projects?

Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the future.

Deine Aufgaben

• Risk Management (ISO 14971): Collect and structure input from cross-functional teams and apply the risk management process to compile complete and compliant documentation for the DHF and DMR.
• Design Verification & Process Control: Support the definition of design verification and process control activities and provide recommendations on device-related risks and design decisions.
• Scientific Documentation: Write clear and scientifically robust documents for external partners, regulatory submissions, and interactions with Health Authorities.
• Technical Guidance & Knowledge Sharing: Offer scientific and technical guidance and actively foster knowledge exchange within and across teams.
• Project Planning & Coordination: Develop detailed project plans and timelines together with your manager and align these with the cross-functional development team.

Dein Profil

Minimum Requirements:

• Educational Background – Engineering Degree: You hold a Master's degree in Engineering or a related field (Medical Engineering, Mechanical Engineering, Process Engineering, Electrical Engineering, Computer Science, or similar) or have equivalent professional experience.
• Language Skills – English: You have excellent written and spoken English; German skills are a plus.

Preferred Requirements:

• Industry Experience – Medical Devices / Pharmaceutical: You ideally have prior experience in medical device development or the pharmaceutical industry.
• Risk Management – FMEA & ISO 14971: You are familiar with risk management methods such as FMEA and standards like ISO 14971.
• Software Skills – Polarion: You have experience using Polarion or similar tools for project and requirements management.

Deine Benefits

• Exciting, self-organized and responsible tasks
• Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
• Flexi time agreement, flexible working time model, work-life balance
• Opportunities for specialization and subject-specific further education and training
• Extremely collegial team with a friendly approach
• Various development opportunities within the TECCON Group

The gross annual salary is at least EUR 73.000 but of course we offer overpayment in line with the market, depending on qualifications and professional experience.

Ihre Ansprechpartnerin

Renate Stefanowski

renate.stefanowski@teccon-consulting.com

TECCON Consulting GmbH
Am Tabor 36
1020 Wien