Research and Development Senior Engineer

Role:

Develop and improve endovascular medical devices, ensuring alignment with customer needs and regulatory requirements.

Responsibilities:

• Translate marketing requirements into product development.
• Manage engineering change orders.
• Support clinical complaint investigations.
• Test prototypes and develop new test methodologies.
• Generate regulatory reports.
• Develop solutions to enhance the endovascular product pipeline based on clinical usage.
• Lead new product development through FDA approval.
• Contribute to Premarket Approval (PMA) submissions.
• Manage supplier and subcontractor communication.
• Adapt devices for new markets.
• Collaborate with other departments for seamless product development and improvements.

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 3-5 years of R&D experience in medical devices, preferably cardiovascular or endovascular.
• Strong analytical and problem-solving skills with attention to detail.
• Proficiency in CAD software (SolidWorks preferred).
• Effective communication skills for cross-functional teamwork in a multinational environment.
• Fluent written and spoken English.