We are assisting SmartCella in finding a proactive and technically skilled Technical Lead to drive the development of an innovative catheter-based medical device!

About the company

SmartCella is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. Founded in 2014, the company is built on globally renowned science and research from Karolinska Institutet in Sweden. The company currently has approximately 80–85 employees and will continue to grow coming years.

SmartCella combines novel delivery platforms, such as the Extroducer®, an endovascular delivery device that enables direct injection to hard-to-reach organs and tissues, with state-of-the-art development and manufacturing of cell therapies. The company operates in two business segments: Targeted Delivery and Regenerative Medicines.

As Technical Lead – Product Development, you will be part of the Targeted Delivery division. Please read more about that business segment here!

About the position

As Technical Lead – Product Development, you will play a key role in SmartCella’s exciting journey of growth and innovation. This role is critical in overseeing the full R&D cycle, from concept development through prototyping, verification, validation, and design transfer. The position requires a balance of hands-on engineering, project leadership, and cross-functional collaboration.

Key responsibilities:

· Lead technical development projects, including new product development and product upgrades.

· Serve as the Design Responsible for assigned catheter-based products.

· Define and refine design inputs and requirements in collaboration with internal and external stakeholders.

· Manage design documentation, including design outputs, risk assessments, test plans, and technical reports.

· Interface with clinicians and end-users to gather requirements and evaluate usability.

· Plan, track, and communicate technical progress and milestones to stakeholders.

· Drive continuous improvement of internal R&D and cross-functional processes.

Who we are looking for

You possess strong organizational and leadership skills, with the ability to manage long-term projects and coordinate cross-functional teams. Further, you have a results-oriented mindset, with a high degree of initiative and follow-through and you communicate and document effectively in both technical and cross-disciplinary contexts.

Qualifications:

· University degree in Mechanical Engineering, Biomedical Engineering, Chemistry, Chemical Engineering, or a related discipline.

· Minimum of 3–5 years of experience in medical device product development, preferably with catheter-based systems.

· Proven experience in verification and validation of medical devices.

· Solid understanding of regulatory and quality frameworks, including ISO 13485, FDA QSR, and EU MDR.

· Proficiency in risk management methodologies, particularly in accordance with ISO 14971.

Additional information

This is a full-time position at SmartCella

Office location: Tullinge, Stockholm

In our recruitment processes we use continuous selection. This means that we review and process applications for the position and conduct interviews continuously. If you find an interesting position with us, we therefore recommend that you apply for the position as soon as possible. You apply for our positions by registering your CV and answering the selection questions for each position, with us you apply without a personal letter and instead you get the chance to motivate your interest in the position in the questions in the application form.

Do you have any questions about the position?

Please feel free to contact Anna Maria Lindqvist.

Anna Maria Lindqvist: 070 589 23 19 / anna-maria.lindqvist@medhouse.se

We look forward to receiving your application!