Product Development Engineer

SmartCella Holding AB; Tullinge; Presencial; SEK 700.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation & benefits

International team

Descripción de la vacante

Smartwise Sweden AB in Sweden is seeking an experienced Product Development Engineer to develop minimally invasive medical devices, with a focus on catheter-based endovascular technologies. You will oversee product development across the lifecycle and collaborate with R&D, Quality, Regulatory, suppliers, and manufacturing partners.

This hands-on role requires strong problem solving, ownership, and the ability to translate complex requirements into robust, manufacturable solutions with clear

Formación

• Bachelor's or Master’s degree in Mechanical or Biomedical Engineering.
• 5+ years in medical device product development or design engineering.
• Experience with engineering changes and design control.
• Hands-on testing, verification, validation, and documentation.
• Knowledge of ISO 13485, ISO 14971 and medical device regulations.
• Strong cross-functional collaboration with suppliers and manufacturing partners.
• Excellent analytical, problem-solving, and organizational skills.
• Ability to communicate in English and Swedish.

Responsabilidades

• Develop and lead product development, changes, and new variants.
• Plan and perform design verification and validation testing.
• Maintain design documentation, BOMs, and design files.
• Coordinate with suppliers and manufacturing partners on components and processes.
• Support design transfer and regulatory compliance.

Conocimientos

Medical device experience

English & Swedish communication

Analytical skills

Educación

Bachelor’s or Master’s degree in Mechanical/Biomedical Engineering

Descripción del empleo

Turn Innovation into Life-Changing Medical Technology

About The Role

Smartwise Sweden AB is looking for an experienced Product Development Engineer to develop minimally invasive medical devices, with a focus on catheter-based endovascular technologies.

You will work across the product lifecycle—from new development and product improvements to new configurations—partnering with R&D, Quality, Regulatory, suppliers and manufacturers to deliver safe, robust and manufacturable solutions.

This is a hands‑on role with ownership, complex problem-solving and a clear impact on next‑generation medical technology.

What You’ll Do

Develop Products

• Participate and lead product development, design changes, improvements and new variants.
• Develop and assess technical solutions, prototypes and product configurations.
• Implement engineering changes with safety, performance and manufacturability in focus.
• Maintain specifications, drawings, bills of materials (BOMs) and design documentation.
• Support design reviews, design control and risk management in line with ISO 14971.

Test and Solve

• Plan and execute engineering testing, design verification and validation.
• Create test methods, protocols and reports.
• Troubleshoot product issues, lead root‑cause analysis and support CAPA.

Drive Delivery

• Maintain design documentation and medical device technical files.
• Work with suppliers and manufacturing partners on components, processes and improvements.
• Support design transfer and implementation in manufacturing.
• Coordinate engineering activities in line with project plans, quality procedures and regulatory requirements.

What You Bring

Must have

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering or a related field.
• 5+ years in medical device product development or design engineering.
• Experience with product modifications, engineering change management and design control.
• Hands‑on experience in testing, verification, validation and technical documentation.
• Knowledge of ISO 13485, ISO 14971 and relevant medical device regulations.
• Experience working across functions and with suppliers and manufacturing partners.
• Strong analytical, problem‑solving and organizational skills.
• Ability to manage engineering activities independently and communicate effectively in English and Swedish.

We believe you are established in Sweden and live in the Stockholm/Uppsala region.

Nice to Have

Additional experience with minimally invasive devices, particularly catheter‑based endovascular systems, would be valuable. We also welcome experience in technical investigations, root‑cause analysis and CAPA, as well as working with contract manufacturers and external test laboratories. Knowledge of design for manufacturing and assembly (DFM/DFA) is an advantage.

Who You Are

You are structured, practical and detail‑oriented, with an analytical and solution‑focused mindset. Proactive and accountable, you manage priorities confidently and collaborate effectively in multidisciplinary R&D teams. Above all, you are motivated by medical innovation and the opportunity to improve patient care.

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.

We offer you to be part of an innovative journey pioneering new treatment paradigms based on world‑class science, a workplace where everyone feels valued, respected, and integral to the company’s success, a transparent culture where vital information is shared across the organization and competitive compensation & benefits.

The SmartCella group consist of SmartCella Holding AB, SmartWise Sweden AB and SmartCella Solutions AB with a total of 38 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.