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Lead Biomedical Engineering Specialist
2 months ago
Position Title: Lead Biomedical Engineering Specialist
Company: InfoTree
Job Duration: 8 Months
Essential Skills Required:
- Expertise in medical device documentation for compliance audits (both written and verbal communication)
- Strong collaboration and teamwork abilities
- Proactive approach to achieving objectives
Key Responsibilities:
The role involves the creation of standard and regulatory documentation to identify gaps, formulate plans, and provide evidence of completion. You will be responsible for initiating and leading cross-functional meetings to ensure alignment with Subject Matter Experts (SMEs) across various domains including sterilization, packaging, labeling, regulatory affairs, risk management, and product release (software and electrical engineering) as well as the project team. The goal of these meetings is to facilitate the authorship and execution of documentation approvals to meet project milestones.
Additionally, the position entails designing, developing, and conducting safety evaluations, repairs, and maintenance of biomedical devices. You will ensure that all biomedical equipment adheres to relevant regulatory standards and quality control measures. Responsibilities also include designing studies and performing research on enzyme reactions and the impact of organic compounds on biological systems. Participation in activities such as compound screening, optimization programs, and the development and execution of enzyme assays will be expected.
