Job Description SummaryAs directed by the Sr. Quality Manager, the Staff Software Quality Engineer I is responsible for representing the Unit Quality function regarding all activities associated with the development and implementation of medical device and non-medical products incorporating software/firmware. This person will handle projects and tasks from product inception through product launch and maintenance and play an active role in the software development processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements. # Job Description Responsibilities: + Provide coordination and guidance to cross functional teams to ensure software quality objectives are met for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices + Identify software quality challenges and software quality improvement opportunities + Reviews and approves project documentation including Software Development Plans, Software Requirements Specifications, Software Design Documents, Software Test Plans/Protocols/Reports + Provides training for product development teams and continuous improvement team on best practices + Assist in audits for the products under review as needed. + Writes and leads risk management activities including risk management reports, software risk analysis, hazard analysis and risk management files. + Support of the following, however are not limited to: - Design Control - Software Lifecycle Process - Change Control - Risk Management - Identification of CTQ's - Manufacturing equipment Software validations/Computer system validations - Post Market Surveillance - Situation Analysis - CAPA - Root cause investigation and implementation of corrective/ preventive actions + Guides the successful completion of major programs and may function in a project leadership role + Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations + Decisions, recommendations and results further the achievement of goals critical to organizational objectives + Implements and communicates the strategic and technical direction for the product/project team + Identifies any issues that may delay product or project and recommends appropriate action to be taken + Works under consultative direction toward predetermined long-range goals and objectives + Creates and supports documentation + May be assigned as core team or extended core team member Qualifications + Bachelor’s degree in a technical discipline, preferably Computer Sciences, Information Technology, or other Software Engineering related discipline + A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience + Demonstrate functional knowledge and expertise software development, software lifecycle (SDLC) processes, regulatory requirements, international standards, and risk management + Prior experience with Regulated software development - Class II / III medical device experience preferred + Extensive knowledge of applicable regulatory, Corporate and / or Unit requirements + Strong knowledge of Software Development Lifecycle Processes per IEC-62304, and Cyber Security requirements for medical devices + Understanding of 21CFR820, ISO 13485, , IEC-60601, IEC-62366 + Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication + ASQ Certificate(s) desirable (but not required) + Design for Six Sigma preferred + Knowledge of Agile development process and tools preferred # Primary Work LocationUSA NJ - Franklin Lakes # Additional Locations # 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.