Engineer,Regulatory Compliance

JOB SUMMARY: Evaluate, select, and apply standard engineering techniques, procedures, and criteria, using judgment in making decisions, in the evaluation of product models to the applicable safety compliance standards.? Assignments will have clear and specified objectives and require the investigation of a wide number of variables.?? ? ESSENTIAL/PRIMARY DUTIES: Assures that products are designed and tested in compliance with all applicable safety agency requirements, as well as all quality-related aspects of the project.? Ensures maintained compliance to all applicable safety standards and safety agency requirements. Coordinates and participates with engineering teams on design compliance to safety standards; construction, charts, critical components lists and acts as a technical liaison and consultant. Coordinate and participate with engineering teams on risk management activities for compliance relative to safety standards and the creation of critical to quality device items. Manages the creation of required compliance documentation and test records. Conducts required product model compliance testing activities as specified by applicable compliance standards and Midmark procedures and work instructions.? Directs as required other technical personnel that are conducting compliance testing activities. Conducts audits as required throughout the life of a device to ensure hazard mitigation and safety compliance is maintained Actively involved in the evaluation of product model design, ensuring that the product is safe and effective for production and sale to the public. Coordinates activities with regulatory agencies as an integral process of evaluating product models for compliance to applicable standards. Carry out compliance engineering liaison activities with other areas of the company, as required, and actively participates in project team meetings and related activities as needed. ? ? SECONDARY DUTIES: Design and implementation of automation test equipment and software. EDUCATION and/or EXPERIENCE: Bachelor's degree in a technical discipline and 5 years work experience in a medical product development environment or similar capacity and/or graduate level education providing equivalent capabilities. ? ? COMPETENCY/SKILL REQUIREMENTS: PC office applications Ability to use complex test equipment Ability to coordinate and maintain multiple project work simultaneously Strong analytical and communications skills Written and verbal communication skills Analyze and interpret data Prepare test Protocols and Test Reports Microsoft Office Suite Microsoft Outlook ? ? SUPERVISORY RESPONSIBILITIES:? N/A - provided by Dice
Development, Management, Outlook, PC, Project, Protocols, Risk Management, Testing


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