System Engineer Role in Medical Device Development

We seek a System Engineer to lead the technical development of cutting-edge medical devices in collaboration with our client's customer partners. This fast-paced role requires a visionary with a proven track record in technical product development and product launches . If you're ready to make an impact, we want to hear from you!

Key Responsibilities

• Manage and develop product requirements.
• Define system architecture, including interfaces and interaction diagrams.
• Conduct risk management activities like DFMEA.
• Drive concept development, evaluation, and selection.
• Select key technologies and components.
• Oversee hardware/software integration.
• Collaborate with the product verification team on test method development.
• Participate in prototype builds and troubleshoot technical issues.
• Act as the primary technical interface with customer teams.

Required Expertise:

• Strong critical thinking and decision-making skills.
• Ability to work closely with project managers and drive team action.
• Excellent communication skills, especially for conveying complex concepts.
• Knowledge of medical device standards and regulations (e.g., IEC 60601, ISO 11608).

Desired Skills:

• Experience with eco-design techniques.
• Proficiency with tools like Modern Requirements or APIS (DFMEA).
• Familiarity with MatLab/Simulink.
• Background in manufacturing process development.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Software, or Biomedical Engineering.
• 10+ years of relevant experience in medical device development.
• Proven ability to manage design cycles from concept to production.