Product Development Manager

We're Looking for Medical Device Design Manager / Product Development Manager

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.