Systems Engineer | 2C ENGINEERING

SYSTEMS engineer

April 2025

2C ENGINEERING is an engineering consultancy working with some of the most innovative companies in Denmark. Both the large well-established ones such as Novo Nordisk and Ambu, but also small ambitious start-ups like CSF-Dynamics and Nerve Smart Systems. Our consultants either work in-house with our clients (usually in the Greater Copenhagen area) or at our offices in Lyngby (20 mins outside Copenhagen), depending on the project.

2C ENGINEERING’s clients need consultants to perform versatile and exciting tasks that will most likely include idea and concept development, detailed construction, fixed prototyping, testing, and documentation. These are roles helping create new innovative products which are essential for for the client business and provide value for the end users. We currently also often have roles for testing of legacy medical devices and protocol writing within the context of MDR compliance for devices already on the market.

2C ENGINEERING was established in 1999 and we have approximately 20 employees, many of whom are long-standing. We are a dynamic company where you can make your influence felt and where you will be part of a professional committed team. Regardless of the assignment locations we all meet on a monthly basis at the 2C offices to inspire each other and draw on common skills and experience. We have great facilities including our "Innovation Lab", where we build models and machines and realise solutions. We are located in Lyngby, walking distance from the train station and the vibrant Lyngby high street.

SYSTEMS ENGINEER

Are you an experienced System Engineer with expertise in medical devices and product approvals? Do you have a strong background in working with ISO 13485, FDA approvals, and MDR directive/MDD? Do you possess a systematic approach to work and a broad multi-technical understanding? If the answer is yes, you might be our next System Engineer at 2C A/S!

Responsibilities: As a System Engineer at 2C A/S, you will play a pivotal role in the development, documentation, and approval of medical devices. Your main responsibilities will include:

Working within the framework of ISO 13485 standards and having experience navigating the FDA approval process and MDR directive/MDD.
Applying your multi-technical understanding to analyze and comprehend complex products and their interconnections.
Experience across all disciplines of the V-model, including requirement specifications, design, testing, verification, and validation.
Performing risk assessments and preferably usability analyses to ensure safety and user-friendliness.
Implementing changes to products in accordance with applicable standards and regulations.
Updating documentation to align with changes and requirements.
Supporting audits and inspections, ensuring the company's adherence to relevant standards and guidelines.

Qualifications:

Minimum of 3 years of relevant experience in medical devices and product approvals.

Experience as a consultant within the field is a strong advantage.
Proficiency in the Microsoft Office suite.
Experience with project management.
Familiarity with systems like Agile, Veeva Vault or similar is a bonus.

Personal Attributes:

Systematic approach to work with attention to detail.
Strong analytical thinking and problem-solving skills.
Self-driven and proactive, with the ability to work both independently and as part of a team.
Excellent communication and collaboration abilities.
Capacity to manage tight deadlines and work in a dynamic environment.
A nice person and colleague

What We Offer: We offer an exciting position in a continuously evolving company. You will become part of a dedicated team of experts and have the opportunity to influence and shape the processes surrounding product development and approval. Professional development and further education opportunities will be available.

If you meet the above requirements and wish to elevate your career as a Systems Engineer at 2C A/S, please submit your application and CV to job@2c.dk.

2C A/S is a leading company in the field of medical devices, dedicated to developing innovative solutions that enhance patient safety and healthcare. We look forward to welcoming a passionate and experienced Systems Engineer to our team.

f you have any questions, please feel free to contact Lars Ulrik on (+45) 22 21 22 37. We recruit on a continuous basis.