Senior Biomedical Equipment Engineer
2 weeks ago
Position: Senior Biomedical Equipment Engineer
Location: Minneapolis, Minnesota (Onsite)
Employment Type: W2 Contract
Essential Qualifications:
Proficient in creating comprehensive documentation for medical device audits, effective communication skills (both written and verbal), and a strong ability to collaborate within a team environment.
Key Responsibilities:
1. Facilitate meetings and collaborative discussions with the Neuro Standards Team, including interactions with Subject Matter Experts (SMEs) across various domains such as sterilization, packaging, labeling, regulatory compliance, risk management, and product releases.
2. Collaborate with the team to develop and secure approval for essential documentation.
3. Engage in the documentation process for all Neuromodulation and Pelvic Health Release Products, which encompass external devices, stimulators, pumps, catheters, leads, and accessories.
Experience Requirements:
A minimum of 1 to 4 years of experience in medical device documentation for audits is required, with at least 1 to 2 years of hands-on experience in the field.
Additional Responsibilities:
Develop standard and regulatory documentation to identify gaps, outline plans, and provide evidence of completion.
Initiate and lead cross-functional meetings to align with SMEs and project teams, ensuring the documentation process meets project objectives.
The goal of these alignments is to effectively author and execute documentation approvals to meet monthly project targets.
Design, develop, and ensure the safety testing, repair, and maintenance of biomedical equipment.
Verify that all biomedical equipment adheres to relevant regulatory standards and quality control measures.
Conduct research and design studies focusing on enzyme reactions and the impact of organic compounds on biological processes.
Participate in compound screening and optimization programs, as well as the development and execution of enzyme assays.
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