Product Engineer

How you will make an impact Responsible for reviewing complaints related to potential medical device issues. Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge. Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements. Identify and make sound decisions regarding medical device reporting to regulatory agencies. Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies. Participate in audits and CAPA investigations as they relate to complaint handling. Work with the forensic investigation team to align product investigations related to complaints. Generate reports to identify areas of process improvement. Develop product training aids. Contribute independently while also collaborating with other team members and departments needing product complaint information. Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors. Serve as a subject matter expert on complaint handling. Perform other related duties as assigned under management supervision. Skills needed to be successful 4-year biomedical engineering degree; OR 2-year biomedical engineering degree and 2+ year(s) relevant experience in a cGMP environment supporting complaint handling investigations, medical device reporting, or product analysis. Experience in complaint handling or quality engineering preferred (school projects and internships considered) Knowledge of FDA requirements for Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. Experience with SalesForce is preferred. Strong motivation to see individual tasks through to completion, and to help as needed to achieve team goals. Exceptional time management skills with the ability to prioritize multiple projects and ensure compliance with regulations and standard operating procedures. Good problem-solving and proficient computer skills are required. Solid written/verbal communication and organizational skills, as well as attention to detail. Sound technical writing skills. Ability to work well independently and on cross-functional teams in a fast-paced, changing environment. #J-18808-Ljbffr