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Senior Biomedical Engineering Specialist
2 months ago
Job Overview:
ATR International is looking for a Senior Biomedical Engineering Specialist to support critical projects.
Key Responsibilities:
1. Achieve monthly documentation approval targets by facilitating meetings and collaborations with the Neuro Standards Team and Subject Matter Experts (SMEs) across various domains including sterilization, packaging, labeling, regulatory compliance, risk management, and product releases.
2. Collaborate with the team to develop and obtain approval for essential documentation.
3. Support all Neuromodulation and Pelvic Health Release Products, including external devices, stimulators, pumps, and related accessories.
4. Create regulatory documentation to identify gaps, outline plans, and provide evidence of completion.
5. Initiate and lead cross-functional meetings to align with SMEs and project teams, ensuring documentation approval aligns with project timelines.
Additional Responsibilities:
1. Design, develop, and ensure safety testing, repair, and maintenance of biomedical equipment.
2. Ensure compliance of biomedical equipment with applicable regulatory standards and quality control measures.
3. Conduct research on enzyme reactions and the impact of organic compounds on biological processes.
4. Participate in compound screening and optimization programs, as well as enzyme assay development and execution.
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 and independently under limited supervision, with a focus on achieving project goals.
Organizational Impact:
Responsible for significant projects or processes within the job area, contributing to work group objectives through effective relationship-building and consensus.
Innovation and Complexity:
Ability to tackle complex problems requiring an understanding of multiple specialties, and make process improvements to enhance job performance.
Communication and Influence:
Engage with senior internal and external stakeholders to exchange information and influence decision-making.
Leadership and Talent Management:
May provide guidance and training to colleagues, manage projects, and oversee the work of others.
Required Knowledge and Experience:
Advanced knowledge of the job area, typically obtained through higher education and relevant experience. A University Degree with a minimum of 4 years of relevant experience is required, or an advanced degree with at least 2 years of relevant experience.
