Test Engineer

Start your engineering career by helping shape the future of medical device innovation Hands-on testing • Collaboration • Meaningful innovation Are you a hands-on engineer who enjoys testing, problem-solving, and turning data into practical improvements? We are looking for a curious and structured Test Engineer to join our R&D team and support the development of safe, high-quality medical device solutions. About the role In this role, you will plan, perform, document, and analyse engineering tests for products, prototypes, components, and test methods. You will work closely with colleagues across R&D, Operations, Quality Assurance, Regulatory Affairs, Manufacturing, Clinical Affairs, and external suppliers. You will be part of a collaborative environment where practical engineering, quality, and continuous improvement go hand in hand. The role reports to the Head of R&D and Clinical Affairs. What you will doTesting, verification and method development Plan, conduct, and document verification, validation, feasibility, and routine engineering tests.

Analyse test data, interpret results, and prepare clear reports with recommendations for improvement.

Develop and improve test procedures in line with project needs, safety requirements, and quality expectations.

Equipment, calibration and quality support Support equipment maintenance, calibration, gauge R&R activities, and method verification or validation when needed.

Contribute to safe, compliant, and well-controlled laboratory and manufacturing-related testing activities.

Collaboration and continuous improvement Collaborate with cross-functional teams to troubleshoot testing, process, and equipment-related challenges.

Work with suppliers and vendors to support installation, maintenance, and continuous improvement of equipment and systems.

Compliance and safety Together with QA/RA, you will help ensure that testing is performed in line with internal procedures, safety requirements, and relevant standards such as ISO 13485, ISO 14971, ASTM standards, FDA Quality System requirements, and EU MDR where applicable. Who we are looking forA great opportunity to grow This is a great opportunity for someone early in their engineering career who wants to grow in an exciting and meaningful field. We are looking for a curious, structured, and hands-on person who enjoys learning, solving problems, and working closely with others to turn ideas and test results into practical improvements.

You have a Bachelor’s or Master’s degree in Mechanical Engineering, Industrial Engineering, or a related field, together with some relevant experience from engineering testing, validation, laboratory work, product evaluation, internships, academic research, or engineering projects.

You have a basic understanding of test design, validation principles, structured documentation, CAD software, and data analysis tools — and you are eager to keep developing your skills.

Nice to have Experience from the medical device industry, particularly catheter development or manufacturing, is an advantage. Proficiency in Swedish is also a plus. Practical information The role includes work in both office and laboratory or manufacturing environments, with a strong focus on safe and compliant ways of working. Why join us? You will join a team where your curiosity, practical mindset, and attention to quality can make a real difference. Together, we develop solutions that support meaningful progress in medical device innovation. Interested? Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible. The SmartCella group consist of SmartCella Holding AB, SmartWise Sweden AB and SmartCella Solutions AB with a total of 32 employees from 11 nationalities. We are a global drug delivery company pioneering innovative delivery solutions for targeted therapies, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors). We are an international and diverse team of scientists, visionary innovators, and experienced business leaders, dedicated to shaping the future of targeted therapies.