Design Assurance Engineer Location: Minneapolis, MN, US Job Family: Quality Assurance Country/Region: United States The Interventional Urology Design Assurance Engineer is responsible for supporting new product development and commercialized products. Major Areas of Accountability Participate in New Product Development Phase Reviews; lead/participate in Design Reviews. Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships. Review and support Electrical and Software Design Inputs, Design Verification and Test Readiness Reviews Work with R&D team and 3rd party software/electrical consultants to complete project deliverables Ensure relevant design standards are appropriately applied and satisfied. Create and support the development and validation of new test methods. Determine and document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA). Support the execution of design verification and validation, as well as usability. Generate/support test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing, including shelf life and stability. Drive improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency. Support regulatory approvals and responses to regulatory questions. Manage the stability test program Support and execute design and process changes to commercialized product. Support the transfer of new product development projects from development to production. Support internal and external audits. Manage statistical support for test method validations, sample size requirements, etc. Interacts with external contract manufacturers and suppliers Provide technical support based on overall project plans with the development of products in compliance with design controls, international standards, and FDA or other regulatory body guidelines. Manage product stability program to ensure all products have adequate heat-age and real-time aging for support of shelf life. Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies. Other duties may be assigned. Basic Qualifications BS in Engineering (Electrical or Software Engineering preferred) 2+ years related experience and/or training ASQ Certified Quality Engineer preferred Competencies Ability to work independently and with general direction. Ability to define, organize, and manage individual and team-based tasks. Provide direction to extended team members. Good written and verbal communication, with strong technical writing skills. Understanding of design controls, risk management, statistics, test method validation, and new product development processes. Knowledge and application of FDA, QSR, ISO 13485 and ISO 14971 requirements. Structured and methodical problem-solving approach. Ability to travel up to 10%. Personifies and fosters the Coloplast Mission, Vision and Values. Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things. Visit us onColoplast.com. Watch the film.Follow us onLinkedIn. Like us onFacebook. Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies. Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which me ns we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification. 57423 #LI-CO Nearest Major Market: Minneapolis Apply now Find similar jobs: EOE M/W/Vets/Disabled