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Clinical Design Engineer
- Posted: 11/05/2024
- Salary: Competitive
- Location: Arden Hills, Minnesota, United States
- Job Type: Permanent/Fixed Term
Responsibilities
The Clinical Design Engineer will be responsible for designing and managing a research and development (R&D) medical device feasibility studies. We are looking for somebody with the appropriate blend of technical, regulatory, and project management skills.
Technical Skills
Travel:
Qualifications
The Clinical Design Engineer will be responsible for designing and managing a research and development (R&D) medical device feasibility studies. We are looking for somebody with the appropriate blend of technical, regulatory, and project management skills.
Technical Skills
- Medical Device Design and Development: Understanding the principles of medical device design, including knowledge of materials, mechanics, and electronics.
- Regulatory Knowledge: Familiarity with regulatory requirements such as FDA's Investigational Device Exemption (IDE) and Early Feasibility Studies (EFS) guidelines.
- Clinical Trial Design: Experience in designing clinical trials, including protocol development, statistical analysis, and data management.
- Design Quality Assurance: Proven experience in managing new product development projects within a quality management framework
- Project Planning and Execution: Ability to plan, execute, and manage projects, including budgeting, scheduling, and resource allocation.
- Risk Management: Skills in identifying, assessing, and mitigating risks associated with medical device development and clinical trials.
- Team Leadership: Experience in leading multidisciplinary teams, including engineers, clinicians, and regulatory experts.
- Stakeholder Communication: Ability to communicate effectively with stakeholders, including regulatory bodies, clinical sites, and patients.
- Ethical and Regulatory Compliance: Strong understanding of ethical considerations and regulatory compliance in clinical research
- Problem-Solving: Strong analytical and problem-solving skills to address challenges that arise during the study.
Travel:
- Hybrid (3 days a week onsite: Tuesday, Wednesday, Thursday)
Qualifications
- A master’s or doctoral degree in biomedical engineering, medical physics, life sciences, or a related field is required.
- Certifications such as Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) would be beneficial.
- Several years of experience in medical device development, clinical research, or a related field.
- Direct experience developing clinical research studies, preferably with medical devices.