Plexus Corp Sr Quality Engineer Medical Device Development in Boulder, Colorado

Job OverviewThe Quality Engineer for Medical Device Development will serve as the focalpoint for the project team and the customer on topics related to safety agencyand regulatory compliance as well as the necessary quality system(s). TheQuality Engineer has overall responsibility for assuring that the product isdesigned and tested in compliance with applicable domestic and internationalregulatory agencies and/or bodies. This includes but is not limited to:participating in the development of the product specifications, definingproject compliance to internal and external standards, coordinating safetyagency marking and regulatory compliance, coordinating the risk managementand human factors activities, and coordinating design verification testactivitKey Aspects of your Job: * Ensure that the planned project activities are compliant with Plexus'standard operating procedures and ISO (i.e. 13485) quality systems, theFDA Quality System Regulation (QSR) regulations. * Understand Design History File (DHF) content requirements and becapable of performing all aspects of DHF maintenance. * Support proposal activities for new business and other marketingsupport as requested. * Participate in the Plexus quality system development and maintenance. * Understand medical device safety standards (i.e. IEC 60601-1),regulatory requirements, and be capable of identifying those that areapplicable for each unique product. * Determine appropriate specifications to comply with regulatory andcompliance requirements of intended markets. * Mentor and lead the project team on regulatory and safety agencycompliance requirements of intended markets. * Facilitate documentation of functional, electrical and mechanicalspecifications. * Lead the development of the product Risk Management Plan and maintaincustomer specified content of the Risk Management File for each uniqueproduct. * Lead product Risk Analysis meetings and document the results asspecified in ISO 14971. Follow up as required throughout the project to ensureadherence to risk management plan. Risk activities also include coordinationof Design Failure Modes and Effect Analysis reports, Fault Tree Analysis,and other risk reports. * Coordinate device reviews with safety agencies. * Coordinate all Design Verification Test activities, includinggeneration of the verification Plan, Procedures and Report documents. * Review design related project documents and drawings to ensure internaland external requirements are met. * Participate in engineering reviews to ensure they are conducted anddocumented as appropriate.What you need to be Successful in your Job: * Possess a strong working knowledge of medical device and similar safetystandards (i.e. IEC 60601-1, IEC 61010-1) * Possess understanding of regulatory requirements such as FDA QualitySystem Regulations, ISO 13485 and the EU Medical Device and In VitroDiagnostic Medical Device Directives * Experience with the development of risk management planning andanalysis as defined in ISO 14971 * Experience with Design Verification Test activities including testplanning, test procedure and test report development * Experience working with safety agency test labs for agencycertifications such as UL, CSA, CE, etc. * Possess at least basic knowledge of the Software Quality Engineeringfunctions * Possess excellent verbal and written communication skills as well asinterpersonal skills necessary to work across multiple engineeringdisciplines, project management, and external customers. * Must be able to work in a matrix style organization on multipleprojects simultaneously.Education & Experience * A Bachelor's degree in a scientific, engineering or equivalentbackground is required for this position * Experience of 5 years in quality engineering for medical device productdevelopment or equivalent is required for this positionQualificationsAll offers of employment are conti