Epicareer Might not Working Properly
Learn More

Medical Device Design Manager

Salary undisclosed

Apply on


Original
Simplified

Overview: We are seeking an innovative and detail-oriented Single-Use Medical Device Designer to join our team. The ideal candidate will have a strong background in medical device design, materials science, and regulatory compliance.

Key Responsibilities:

  • Design and develop single-use medical devices from concept to prototype.
  • Collaborate with cross-functional teams, including engineering, quality assurance, and regulatory affairs.
  • Conduct feasibility studies and risk assessments to ensure device functionality and safety.
  • Create and maintain detailed design documentation, including specifications and drawings.
  • Oversee testing and validation processes to meet industry standards and regulatory requirements.
  • Stay updated on industry trends, materials, and technologies relevant to single-use devices.

Qualifications:

  • Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
  • Proven experience in designing single-use medical devices.
  • Strong understanding of FDA regulations and ISO standards.
  • Proficiency in CAD software and design tools.
  • Excellent problem-solving skills and attention to detail.
  • Effective communication and teamwork abilities.
  • Bachelor’s degree in Biomedical Engineering or related field.
  • 3 years of experience in medical device design, specifically single-use devices.
  • Strong knowledge of regulatory requirements (FDA, ISO) and quality systems (QMS).
  • Expertise in CAD and simulation software.
  • Proven leadership and project management skills.