Product Development Engineer

SmartCella AB; Tullinge; On-site; SEK 750,000 - 950,000; Full time

Job summary

Smartwise Sweden AB is seeking an experienced Product Development Engineer to advance minimally invasive medical devices, focusing on catheter-based endovascular systems. You will collaborate with R&D, Quality, Regulatory, suppliers and manufacturers to deliver safe, robust and manufacturable solutions.

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

Qualifications

• 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.

Responsibilities

• Lead product development, design changes and new variants.
• Develop and assess technical solutions, prototypes and configurations.
• Implement engineering changes with safety, performance and manufacturability in focus.
• Maintain specifications, drawings, BOMs and design documentation.
• Support design reviews, design control and risk management per ISO 14971.
• Plan and execute testing, design verification and validation.
• Create test methods, protocols and reports.
• Troubleshoot product issues and lead root‑cause analysis.

Skills

Analytical thinking

Cross‑functional collaboration

Problem solving

Technical communication

Education

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

Job description

Product Development Engineer

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.