R&D Engineer (Medical Device)

Note: We do not hire C2C

Job Summary:

Seeking a talented R&D Engineer to design and develop new medical devices, particularly leadless pacemaker catheters. The role involves qualifying additional suppliers and ensuring compliance with regulatory standards.

Key Responsibilities:

• Design and develop medical devices from concept to production.
• Conduct feasibility studies and risk assessments.
• Create design specifications and technical documentation.
• Collaborate with cross-functional teams including clinical, regulatory, manufacturing, and quality assurance.
• Perform prototype development, testing, and validation.
• Qualify additional suppliers, holding them accountable to deadlines.
• Support regulatory submissions and product lifecycle management.

Qualifications:

• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or a related field; Master’s or Ph.D. is a plus.
• Minimum of 2 years of engineering experience in the medical device industry.
• Experience with catheter-based devices preferred.
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and MS Office.
• Strong understanding of medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Windchill experience is a plus.
• Strong written and verbal communication skills.
• Ability to work well with others and cross-collaborate effectively.