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Senior Biomedical Engineering Specialist
2 months ago
Job Overview:
ATR International is in search of a Senior Biomedical Engineering Specialist to support critical projects.
Key Responsibilities:
1. Achieve monthly documentation approval targets by collaborating with the Neuro Standards Team and Subject Matter Experts (SMEs) across various domains including sterilization, packaging, labeling, regulatory compliance, risk management, and product release.
2. Engage in meetings and discussions to develop and finalize essential documentation for Neuromodulation and Pelvic Health Release Products, which encompass external devices, stimulators, pumps, and related accessories.
3. Generate standard and regulatory documentation to identify gaps, outline plans, and provide evidence of completion.
4. Facilitate cross-functional meetings to ensure alignment with SMEs and project teams, leading to the successful authorship and execution of documentation necessary for project milestones.
Additional Responsibilities:
1. Design, develop, and conduct safety testing, maintenance, and repair of biomedical equipment.
2. Ensure compliance of biomedical equipment with relevant regulatory standards and quality control measures.
3. Conduct research on enzyme reactions and the impact of organic compounds on biological processes, participating in compound screening and optimization initiatives.
The ideal candidate will have:
1. Experience in medical device documentation for audits, strong communication skills, and a collaborative mindset.
2. Proven ability to work autonomously, demonstrating initiative to meet goals.
Key Differentiators:
1. Autonomy: Operates independently with minimal supervision, developing innovative solutions and mentoring junior specialists.
2. Organizational Impact: Responsible for significant projects, contributing to team objectives through effective relationship-building and consensus.
3. Innovation and Complexity: Tackles challenging problems requiring a comprehensive understanding of various specialties, providing in-depth analysis and recommendations for process enhancements.
Communication and Leadership:
1. Engages with senior internal and external stakeholders to exchange information and influence decision-making.
2. May provide guidance and training to colleagues, overseeing project delegation and review processes.
Required Knowledge and Experience:
1. Advanced knowledge in the field, typically acquired through higher education and relevant experience.
2. A minimum of a University Degree with at least 4 years of experience, or an advanced degree with a minimum of 2 years of relevant experience.