January 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.

 

TEST & VERIFICATION ENGINEER

Are you a skilled Test and Verification Engineer with a proven track record in testing and evaluating medical devices or production facilities according to ISO 13485? Do you excel at creating comprehensive test plans and understanding their relation to the broader Risk Management and Design Control setup? Are you well-versed in current industry standards and regulations, including FDA, ISO, and IEC, that govern testing of medical products and production equipment? If you possess experience in test methodologies, including functional testing, performance testing, and reliability testing, and are capable of analyzing test results to identify challenges and propose design enhancements or process optimizations, you might be the Test and Verification Engineer we are looking for at 2C A/S!

 

Responsibilities: As a Test and Verification Engineer at 2C A/S, your role will encompass a range of crucial responsibilities, including:

• Documented experience in testing and evaluating medical devices or production facilities in accordance with ISO 13485.

• Development of comprehensive test plans and a deep understanding of their interplay with the overall Risk Management and Design Control framework.

• Profound knowledge of current industry standards and regulations, extending beyond ISO 13485 to encompass FDA, ISO, IEC, and other relevant standards.

• Proficiency in various test methodologies, including functional testing, performance testing, and reliability testing.

• Ability to scrutinize test outcomes, identify challenges, and propose improvements in design or process efficiency.

• Keen attention to detail and effective task execution at the appropriate level of precision.

• Strong customer-centric approach, ensuring that testing aligns with client needs and expectations.

• Proficiency in Microsoft Office and ideally experience with platforms like IntraLink and Agile.

• Fluent written and spoken communication skills in both Danish and English.

 

Qualifications:

• Proven experience in testing and evaluating medical devices or production facilities in accordance with ISO 13485.

• Familiarity with Risk Management and Design Control principles and their integration into test planning.

• In-depth knowledge of relevant industry standards and regulations, including FDA, ISO, and IEC.

• Proficiency in various test methodologies, such as functional testing, performance testing, and reliability testing.

• Ability to analyze test results, identify challenges, and propose design or process improvements.

• Meticulous attention to detail and ability to work effectively with precision.

• Customer-centric mindset with a focus on aligning testing efforts with client requirements.

• Proficiency in Microsoft Office; experience with systems like IntraLink and Agile is a plus.

• Fluent written and spoken communication skills in both Danish and English.

 

Personal Attributes:

• Pleasant and approachable personality.

• Thrives in being a part of the strong 2C team while enjoying the diversity of work with customers.

• Adaptable and embraces variety in the day-to-day work environment.

 

What We Offer: We provide a stimulating role in a dynamic company. As a Test and Verification Engineer at 2C A/S, you'll be part of a dedicated team of professionals with opportunities for personal growth and professional development.

 

If you meet the above requirements and are eager to contribute your expertise as a Test and Verification Engineer at 2C A/S, please send your application and CV to job@2c.dk.

 

2C A/S is a leading company in the medical device industry, committed to delivering innovative solutions that enhance patient safety and healthcare. We look forward to welcoming a talented and skilled Test and Verification Engineer to our team.

​

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