Senior Catheter-Based Medical Device Engineer

SmartCella Holding AB; Tullinge; On-site; SEK 700,000 - 900,000; Full time

Benefits offered by this job

Competitive compensation & benefits

International team

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Medical device experience

English & Swedish communication

Analytical skills

Education

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

Job description

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