Systems Engineer for Change Management

About the Role

We are looking for a Systems Engineer to join our medical device development organization and support our products throughout their lifecycle. The role focuses on maintaining the integrity of system design as products evolve, ensuring that updates and improvements are reflected consistently across requirements, verification and validation, usability engineering, and risk management on real, released products.

This position is ideal for a systems engineer who enjoys working with existing products and their evolution over time, or for a QA professional with a strong technical background who wants to move closer to system-level design, architecture, and product technology.

You will join a team of eight Systems Engineers working on our various development projects. In the role you will be working closely together with Mechanical/Electronic/Software Engineers, Regulatory Affairs, and Production to support product updates and improvements.

Key Responsibilities

• Analyze system impacts when products are updated or improved, including effects on:

  • System and product requirements

  • Verification and validation activities

  • Risk management files

  • Usability engineering artifacts

• Support traceability between requirements, risks, tests, and activities across the system lifecycle

• Contribute to planning and execution of verification and validation activities

• Ensure system engineering activities are performed in accordance with:

  • ISO 13485

  • ISO 14971

  • EU Medical Device Regulation (MDR)

• Provide systems engineering input during internal and external audits

• Contribute to continuous improvement of systems engineering methods and tools

Required Qualifications

• Degree in Biomedical Engineering, Electrical/Mechanical Engineering, or similar

• Experience in the medical device industry

• Solid understanding of:

  • Requirements engineering and traceability

  • Verification and validation practices

  • Risk management per ISO 14971

• Working knowledge of ISO 13485 and medical device development processes

Preferred Qualifications

• Knowledge of or exposure to usability engineering / EN 62366

• Background in Quality Engineering or close collaboration with QA/RA

Join us in shaping a company culture that makes Monday mornings worth it.

We are a vibrant, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities who all contribute to a thriving company culture. We partake in social clubs, monthly social activities and various in-team activities as well. If that’s not enough, then add on:

• An attractive healthcare package to keep you fit and well.

• Breakfast every day, and a delicious and healthy lunch cooked by our private chefs.

• Good work/life balance e.g., work from home policy for up to 2 days per week.

• A joint purpose: to enable dentists to provide superior dental care to every patient, every time.

 We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.

About us

3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.