Risk Management Engineer (m/f/d) Medical Devices

TECCON Austria GmbH; Schaftenau; Hybrid; EUR 60 000 - 80 000; Vollzeit

Zusammenfassung

A leading company in IT and engineering is seeking an expert to contribute to exciting projects in risk management and design verification within the medical device sector. The role includes working on regulatory submissions and collaborating with interdisciplinary teams, offering creative freedom and long-term career prospects in a dedicated environment.

Leistungen

Flexible working hours

Remote work options

Development and training opportunities

Engaging team events

Qualifikationen

• Master’s degree in Engineering or related field required.
• Strong command of English, knowledge of German is a plus.
• Previous experience in medical device development preferred.

Aufgaben

• Compile risk management documentation for compliance with ISO 14971.
• Define design verification and process control activities.
• Prepare scientific documentation for regulatory submissions.

Kenntnisse

Risk Management

Scientific Writing

Cross-Functional Collaboration

Project Planning

Ausbildung

Master’s degree in Engineering

Tools

Polarion

Jobbeschreibung

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.

• Risk Management Documentation: Consolidate input from cross-functional teams to compile risk management documentation for the Design History File (DHF) and Device Master Record (DMR) in compliance with ISO 14971.

• Design Verification & Control Strategy: Define and support design verification and process control activities; identify and communicate device-related risks and project challenges to stakeholders.

• Scientific Writing for Regulatory Submissions: Prepare high-quality scientific documentation for external partners and health authorities; contribute to regulatory submission packages.

• Cross-Functional Collaboration: Provide scientific and technical guidance within interdisciplinary teams and actively promote internal knowledge exchange.

• Project Planning & Timelines: Develop and manage detailed development plans and timelines in alignment with project leads and the cross-functional team.

• Educational Background: Master’s degree in Engineering or a related field (e.g., Medical Engineering, Mechanical Engineering, Process Engineering, Electrical Engineering, Computer Science) or equivalent practical experience.

• Language Skills: Strong command of English (spoken and written); knowledge of German is an asset.

• Industry Experience: Previous experience in medical device development or the pharmaceutical sector is advantageous.

• Risk Management Expertise: Familiarity with FMEA, ISO 14971, or similar standards in the field of risk analysis.

• Application Knowledge: Experience with Polarion or comparable requirements and risk management tools beneficial.

• Exciting challenges and responsible tasks with plenty of creative freedom and personal responsibility
• Long-term career prospects in a dynamic and dedicated team
• Flexible working hours and remote work options to support a healthy work-life balance
• Diverse development and training opportunities to help you reach your full potential
• Engaging team events that strengthen team spirit and add variety to your work life

The gross annual fulltime salary is at least EUR 60.000 € but of course we offer overpayment in line with the market, depending on qualifications and professional experience.