Job Description Summary # Job Description We are seeking a Software Quality Engineer with development experience and the ability to work on multiple projects independently and as part of a project team. This person will be an integral part of the both the quality department and development teams contributing to quality plans and design documentation. This candidate will also perform various quality-engineering functions and associated support tasks in driving business objectives, developing knowledge and experience in the areas of ISO13485, 21 CFR 820 and 803 and other relevant standards. Essential Job Functions + Drive improvements in testing and application lifecycle management. + Create and review quality system documents, protocols, process and product validations, and test methods. + Provide support for quality objectives and process improvement efforts. + Coordinate overall compliance administration activities relating to design controls, verifications, validations and qualifications. + Perform internal quality audits and build / review risk assessments. + Develop and apply knowledge around ISO9001, ISO13485, 21 CFR 820/803, and SaMD. + Identify, implement, and monitor procedures and systems to support relevant standards. + Perform general quality control / quality assurance tasks, support product testing and releases as needed. Qualifications: + Ability to perform engineering work of a broad nature with little direction from Quality Management. Generally, receives mentorship on novel or controversial problems. + Knowledge of medical device regulations, industry or international standards, including management responsibility; IEC 62304 Medical Device Software Life Cycle + Experience with Jira, Redmine, Bugzilla, Jenkins, Git, SVN, TFS/Azure DevOps Server, DOORS, Testlink or comparable code management, issue tracking, project planning, documentation and repository tools. Education and Experience: + Bachelor of Science Degree or equivalent experience + 5 – 7 years of demonstrated ability in medical device software as well as establishing and upholding software life cycle processes At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under “Our Commitment to You”. The anticipated compensation range for this position is $65,000 - $90,000 and the compensation offered will depend on the candidate’s qualifications. *BD follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE). Becton, Dickinson and Company is an EqualOpportunity/AffirmativeAction Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At BD, furthering Inclusion and Diversity is not just the right thing to do—it is both a cultural priority and a strategic imperative.One of the many reasons people choose to work at BD is for our comprehensive Total Rewards program aimed at the varying needs of our diverse and global associates. Total Rewards at BD includes base pay, incentives and benefits that support your health and wellness, family, money and lifestyle. #LI-PRO # Primary Work LocationUSA CO - Louisville # Additional LocationsUSA GA - Covington BMD # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.