Medical Device Design Manager
Salary undisclosed
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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.
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