Plexus Corp Spring 2018 Intern Quality Engineer in Boulder, Colorado

THE BOULDER DESIGN CENTERWith a local population that boasts more Ph.D. s per capita than any other UScity, the Boulder Design Center s 50 engineers and designers serve customersin the Western and South-Western United States. Our engineers form aclose-knit, elite team with 16 years of history providing leading companieshigh quality, innovative designs. Situated at the gateway to the RockyMountains, Boulder is a family friendly city with a small town feel,consistently ranked as one of the best places to live in the United States.Featuring a lively arts and culture scene, prestigious universities,Boulder is only miles from world class skiing, trails, and gorgeousmountain scABOUT THE ROLEThe 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 testactivities. Plexus will provide on the job training for this role.JOB RESPONSIBILITIES * 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.SKILLS & ABILITIES * 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 andanalyses 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