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Job Duties:

Translate company needs into engineering requirements for biomechanical test fixtures; Lead and manage the development and commercialization of new and existing medical devices; Lead a team to perform safety risk analysis to assure the safety and efficacy of the biomechanical test protocols, and medical devices, perform technical/functional risk analysis to uncover engineering and project risks, and write biomechanical verification and validation plans and protocols to effectively test medical device designs against requirements and customer needs; Oversee the execution of biomedical verification and validation testing; Manage and maintain biomedical test and data acquisition device drawing packages and BOM; Review biomechanical test data against established pass criteria; Write clear, data-driven technical summaries and test reports; Determine if outside services can be used cost effectively and expeditiously in place of in-house resources; Transfer designs to qualified manufacturing partners to ensure high quality and efficient manufacture of medical devices and test fixturing; Ensure appropriate selection and qualification of vendors and contract service providers; Review research protocols, test procedures, and technical reports necessary for comprehensive validation, and manage process validation for manufactured product and associated assembly equipment, test equipment, and processes at manufacturing partners; Provide technical oversight and support to sustain research and development of medical devices; Train clinical support specialists in understanding design and operation of complex biomechanical test protocols; Provide technical support/consulting to company staff and contract medical device development and manufacturing entities; Manage projects by creating schedules and timelines, creating or using budgets, and overseeing deadlines; Identify and resolve quality issues for new and existing medical devices and methodology; Support development and maintenance of Quality System consistent with ISO 13485 and ISO 17025; Support regulatory filings by communicating with regulatory authorities such as the FDA, regarding licensing and compliance requirements; Perform other duties as assigned.

Job requirements:

Master’s degree in Bioengineering or Biomedical Engineering.

This position also requires experience or education in Biomechanical Modeling, Finite Element Analysis, Research and Presentation in Orthopedics, CAD Modeling, Mechanical Analysis, Troubleshooting and Maintenance of Machinery, Fabrication and Testing, Engineering Warehousing and Logistics, Production Process Control and Analysis.

This position also requires 10%-20% of the work time to travel for manufacturing audits, research presentations and to support clinical trial sites both domestically and internationally.

Email resume to - jeremileasure@mdevdev.com.