Staff Engineer

DUTIES: Perform audits for clients’ medical devices quality systems in compliance with the requirements of ISO 13485 and other regulatory standards such as MDSAP, MDD, MDR. Manage the execution and timely completion of medical device audits of major magnitude and scope in order to bring safe products to market. Complete audits that include regular quality system and technical audits, as well as unannounced CE audits. Determine the scope of the audit, develop a preliminary plan of investigation, and establish programs for product investigations. Participate in the development of internal UL requirements and assessment methods. Determine areas in which the product is not in compliance with requirements, or of any changes in scope or specifications, and notify the client. Collect and analyze sufficient information in order to make relevant decisions concerning the audit process, including whether or not certification should be recommended or allowed to continue. Review technical documentation related to medical devices. Organize training programs for medical device manufacturers. Integrate continuous improvement concepts and techniques into all aspects of the auditing process. Maintain all audit credentials. Prepare and deliver timely audit reports and provide corrective and preventative action plans. Prepare reports that: describe technical compliance/non-compliance issues; explain procedures and requirements; address client concerns and issues; and include recommendations for certification. Responsible for the overall audit team. Provide leadership, guidance and support to junior audit team members. Monitor performance and provide training, technical advice or counsel when needed. Lead team building activities. 100% telecommuting allowed from anywhere in the United States. Up to 75% domestic and international travel to client locations. 

MINIUM REQUIREMENTS: Bachelor’s degree in Medicine, Pharmacy, Engineering, or related field and 5 years of experience. Must have work experience in each of the following: 1) Active and non-active medical devices; 2) ISO 13485, MDSAP, MDD/MDR, IEC 62304 and ISO 14971; 3) Certification decision maker for ICMED and NABCB 13485; 4) internal or external audit medical management system and supply chain management; 5) Software as a medical device; and 6) MDR experience with a notified body. 100% telecommuting allowed from anywhere in the United States. Up to 75% domestic and international travel to client locations.

Salary Range: $99,403 - $186,800/year.

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