Thursday, November 04, 2010
Engineering Compliance Manager ~ St. Jude Medical (Plano, TX)
The Engineering Compliance Manager is responsible for minimizing risk to the organization associated with pre and post production efforts under governing domestic and international requirements. This position ensures and helps maintain Regulatory Compliance vigilance across the organization in compliance to applicable ISO, AAMI, EN, FDA, FCC, CSA type requirements and serves as the focal point for defining Regulatory Compliance activities.
This position helps define, interpret, and/or ensure the use of, and compliance to, appropriate test standards and regulatory requirements that apply to a medical device manufacturer.
Major, On-Going Responsibilities:
• Identify Regulatory Compliance needs, such as requirements and Testing Standards to project teams, per product type, per desired country of sale.
• Collaborate with Product Development, Manufacturing, Product Assurance to build test matrices per product type per country per appropriate regulations and to streamline product development efforts by designing and standardize testing protocols as appropriate.
• Participate in the review of design documentation to ensure that accepted engineering practices, laws and regulations have been met; obtain interpretations of requirements using international St. Jude affiliates as necessary
• Interact with other departments to provide customers with information concerning product and packaging labeling compliance requirements
• Verify technical content in Design, Manufacturing, and Quality System sections of 510K, PMA, and IDE submission applications per appropriate guidelines and regulations within the scope of the submission strategies and plans.
• Provide project management for cross functional customers on compliance projects
• Remains current on present and pending international and domestic regulatory requirements and testing standards through St. Jude resources, training, external seminars, and reading of technical articles.
• Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.
• Trains the organization on international medical device requirements and standards
• Performs related functions and responsibilities, on occasion, as assigned.
Experience and Training:
• BS in a science related field (biomedical engineering, electrical engineering, biotechnology, biology, chemistry, microbiology, mechanical engineering, etc.)
• Minimum 5 years related work experience; e.g. as Product Designer / Product Development / Project Manager / Microbiologist / Sterilization Specialist / Engineer Regulatory Affairs / Quality Assurance / Quality Engineering.
• Minimum of 2 years experience in a medical device environment.
• Familiarity or experience with domestic and international medical device requirements (such as with the Medical Device Directives AIMD, MDD, CMDR, JGMP, ISO 13485:2003, ISO 14971, ASTM, Sterilization, Biocompatibility ISO 10993, etc.) is highly desired. •Product safety experience and familiarity with EN 60601 and/or other EN, IEC, CSA type standards is desired
• Experience in designing and/or testing of electrical medical devices preferred
• Proficiency with word processing, spreadsheet, data management, process mapping, and project management software programs required
• Technical writing and fundamental problem solving skills required
Apply Online at the St Jude Medical Career site!