Risk Manager (m/f/d) for Medical Devices

Heidelberg Engineering GmbH • Heidelberg

Full-time

Heidelberg

from today

Your responsibilities

Managing risk management for medical devices throughout all life cycle phases. Coordinating the work of interdisciplinary teams of experts in identifying, assessing, and minimizing risks
Supporting technical experts in developing safe system architectures and jointly creating safety concepts to ensure product safety
Creating and maintaining the necessary risk management documentation in compliance with regulatory requirements such as the EU Medical Device Regulation (MDR)
Working closely with those responsible for clinical evaluation to prepare well-founded risk/benefit assessments
Collaboration in the evaluation of complaints and identified product and process errors as part of the corrective and preventive action (CAPA) process
Support for post-market surveillance (PMS), including the evaluation of vigilance/trend data and the derivation of appropriate measures

Your qualifications

Completed university degree in engineering, natural sciences, medical technology, or comparable qualification
Good knowledge of medical technology
Relevant professional experience in the field of medical device risk management or in other regulated, safety-critical areas (pharmaceuticals, aerospace, etc.)
Knowledge of international risk management standards such as ISO 14971 and common risk management methods and tools (e.g., FTA, FMEA, bow-tie analysis)
Experience in quality management systems such as ISO 13485 or FDA QSR/QMSR (21 CFR Part 820)
Knowledge in several of the following areas is desirable:
- Medical electrical equipment and relevant standards (e.g., IEC 60601-1)
- Usability of medical devices (e.g., IEC 62366-1)
- Systems engineering/requirements engineering (e.g., traceability, interfaces, system requirements; ISO/IEC/IEEE 15288, if applicable)
- Software and system architecture and software lifecycle processes/software development (e.g., IEC 62304)
- Functional safety (e.g., IEC 61508)
- Information security / cybersecurity (e.g., IEC 81001-5-1)
- Ophthalmology
Experience in project management and/or research is advantageous

Your profile

Very good written and spoken German and English skills.
Very good analytical skills and confidence in handling data/statistics (e.g., trend analyses).
Ability to weigh risks and benefits in a balanced, fact-based manner, even in situations of uncertainty, conflicting goals, and differing stakeholder perspectives.
Goal-oriented, independent work
Ability to work in a team, very good communication and persuasion skills, and strong moderation skills.
Strong sense of quality and responsibility

We offer

Remote work options to support work-life balance
Flexible working hours based on trust
Attractive location in Heidelberg with connections to the main train station and highway
Subsidized job ticket
Company bike for private use through a bike leasing program
Parking spaces and bicycle storage
Fitness subsidy for Pfitzenmeier, Venice Beach, FitBase, and Urban Sports Club
Attractive, performance-based compensation
Professional development and training opportunities, including access to a digital learning platform
Company pension scheme

It's that easy to apply!

Step 1: Your online application
Simply click on “Apply” and fill out the short application from. This only takes less than three minutes and can also be done on your mobile phone.
Step 2: First Interview
We will get back to you as soon as possible. If there is a fit, we will invite you to a first online interview.
Step 3: In-person interview
If the first meeting went well, we will invite you to another meeting in the office.
Step 4: It's a match? Welcome to Heidelberg Engineering!
You get all documents and information you need for your start and onboarding. We look forward to having you in our Team soon!

Apply now

Our benefits

Employee jubilees:

To show our appreciation, we reward our longstanding employees for company anniversaries and retirements.

Bike leasing:

Whether e-bike or city bike – we offer a bike leasing opportunity to support the health of our employees and to contribute to CO2 neutrality.

Company pension scheme:

We support you in your retirement plans so that you can look forward to the future.

Employee events:

Summer and Winter events, team events or simple after-work get-togethers contribute to a supportive and collaborative culture.

Family business:

Our corporate culture can be described as international environment with a family-like working atmosphere in which you can contribute with your individual skills.

Feedback interviews:

We consider a constructive, reciprocal, and continuous feedback culture as essential for your further development and career planning.

Healthy snacks and hydration:

A weekly delivery of fresh fruits, as well as free water, tea and coffee on site provide you with a good start into the day and boost your energy.

Job ticket:

We support you with our subsidized job/Germany ticket and thereby promote an ecological alternative.

Mobile working:

We offer mobile working options for a better work-life integration and flexibility.

Modern work conditions:

We offer flexible working hours on a trust basis, 30 days of annual leave (based on a 5-day week) and additional leave days for special occasions.

Onboarding process:

Heidelberg Engineering provides you with an individual training plan for your successful onboarding.

Parking opportunities:

Whether by bike, scooter or car – we offer opportunities for parking spaces as well as a separate room to store your bike.

Stay fit:

You can join Pfitzenmeier, Venice Beach, FitBase and Urban Sports Club with our fitness subsidy. With a wide range of gyms, classes and locations, there are plenty of opportunities for you to enjoy.

Top location:

Our attractive location in Heidelberg with direct access to the freeway, public transport and Heidelberg's main railway station make your journey both faster and less complicated.

Training and development opportunities:

Lifelong learning and continuous professional development are among the success factors in the dynamic environment in which we operate. That's why we offer a digital learning platform to expand your professional, social, methodological, and personal skillset.

Corporate Benefits:

Via our free access to our own Corporate Benefits platform we provide several discount codes for our employees with over 800 different brands in various categories such as travelling, fashion, technology, food, mobility, finance, leisure activities and many more.

Do you have any questions?

Feel free to contact our HR Team. E-Mail copied! Copy E-Mail?

Could we convince you?