Senior Medical Device Product Engineer (Catheter-Based)

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

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.