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Process Development Engineer Location: Minneapolis, MN, US Job Family: Research & Development Country/Region: United States The Interventional Urology Process Development Engineer is responsible for supporting new and existing product and process development throughout the development lifecycle. Major Areas of Accountability: Interpret engineering drawings and specifications. Assess product & process risks. Provide statistical inputs to test method validations, sample size requirements, etc. Partner with Sourcing and Supplier Quality on evaluation and selection of contract manufacturers & suppliers Familiar with different device-build processes such as injection molding, transfer molding, dip molding, soldering, crimping, laser welding, adhesives, & ultrasonic welding. Develop device-build processes through screening & range finding studies, then using DOEs to establish process windows. Validate processes by correctly installing equipment (IQ) to operate per requirement (OQ) and safely perform (PQ). Transfer equipment & processes to manufacturing, and train line operators. Responsible for design history file inputs Create device master records Support cross-functional VOC studies. Obtain and maintain all necessary information and experimental test results related to assigned projects by various means of recording Develop product in compliance with design controls, international standards, and FDA or other regulatory body guidance 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 as assigned Basic Qualifications: Bachelor's Degree in engineering, Mechanical preferred +2 years related experience DOE and GR&R experience Good understanding of engineering concepts and principles Familiarity with statistical analysis (e.g., two-sample t-test, tolerance limit calculation) Familiarity with process failure mode analysis (pFMEA, Fault Tree Analysis), hazard analysis and other risk management procedures Good understanding of Quality Management Systems and standard operating procedures Ability to travel up to 10% Knowledge, Skills and Abilities: Ability to work independently or collaboratively Ability to take verbal instructions and translate them into goals and objectives Good written and verbal communication Pro-active; high-performer and results oriented Perform with ethical integrity Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals 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 means 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. 57818 #LI-CO Nearest Major Market: Minneapolis Apply now Find similar jobs: EOE M/W/Vets/Disabled