This design assurance engineer position supports product development to ensure a successful production launch and delivery of the highest quality product to the customer. This position also supports design change and other quality initiatives. This position interacts closely with the Engineering team as well as Operations, Quality Systems, Quality Assurance, Marketing, and Regulatory. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.Location: Must be able to work in Burnsville, MNResponsibilities Executes and supports completion of product development deliverablesCreates and supports development of DHF to ensure content is complete, accurate, and compliant with regulatory standardsSupports the development and maintenance of customer requirements, product requirements, and product specificationsCollaborates cross-functionally to lead and support completion and maintenance of product risk management deliverablesAuthors design verification and design validation plan and report documentsImplements appropriate sampling inspection and supports qualification activities for purchased componentsSupports design test method development, and leads method validation activitiesUtilizes statistical techniques to lead and support characterization, verification, and validation testing and root cause analysisSupport quality system related deliverables including nonconformances and CAPAsPerform other related duties and responsibilities, as assigned.Qualifications Bachelor of Science in engineering3-5 years' experience in Engineering or Quality in the medical device industry.Must be able to work independently under limited supervision.Advanced knowledge of basic Quality Systems and good documentation practices.Experience in investigating and implementing Corrective and Preventive ActionsExperience in design controls and test method validationExperience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.Strong communication skills, both verbal and written.Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.#J-18808-Ljbffr