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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 a critical client.
Key Responsibilities:
1. Achieve monthly documentation approval targets through proactive collaboration with the Neuro Standards Team and Subject Matter Experts (SMEs) across various domains, including sterilization, packaging, labeling, regulatory compliance, risk management, and released products.
2. Collaborate with the team to develop and secure approval for essential documentation related to Neuromodulation and Pelvic Health Release Products, which encompass external devices, stimulators, pumps, and accessories.
Additional responsibilities may include:
- Designing, developing, and conducting safety testing, maintenance, and repair of biomedical equipment.
- Ensuring compliance of biomedical equipment with applicable regulatory standards and quality control measures.
- Conducting research on enzyme reactions and the impact of organic compounds on biological processes.
- Participating in compound screening and optimization programs, along with developing and executing enzyme assays.
The ideal candidate will possess the following qualifications:
1. Proven experience in medical device documentation for audits, along with strong communication skills (both written and verbal).
2. Ability to work collaboratively within a team and demonstrate initiative to meet objectives.
Key Differentiators:
- Autonomy: Operates independently with minimal supervision, developing solutions to complex challenges.
- Organizational Impact: Responsible for significant projects or processes, contributing to the achievement of team objectives through effective relationship-building and consensus.
- Innovation and Complexity: Engages with challenging problems requiring a comprehensive understanding of multiple specialties, proposing enhancements to processes and systems.
- Communication and Influence: Engages with senior stakeholders and external partners to exchange critical information and influence decision-making.
Leadership and Talent Development:
- May provide mentorship and training to colleagues within the job area and oversee project management activities.
Required Knowledge and Experience:
- Advanced knowledge of the biomedical engineering field, typically acquired through higher education and relevant experience.
- A University Degree with a minimum of 4 years of relevant experience, or an advanced degree with at least 2 years of applicable experience is required.
