Senior Quality Engineer - Product Development

We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionJob Summary:This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.Job Responsibilities:Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)Leads development of risk assessments and test methodsLeads component qualifications, design validation / verification and process validationLeads product investigationsAbility to make and present risked based decisionsAssess product changes against product designSupports translation of design inputs into manufacturing control plansDevelop and implement procedures to comply with corporate and industry standards.Coordinates and/or directs all aspects of product development activity related to a product lineQuality engineering representation on Product Development Teams to design, develop, and implement new products and processes for a medical device, translating intangible design inputs into tangible engineering specifications and test plansQuality engineering representation on Design Review TeamsPrepare and present project updates and technical discussionsParticipate in project planning, budgeting, scheduling, and trackingSupport internal and external supplier auditsProvide support to the regulatory department in writing technical submissionsComply with company procedures and policies, government regulationsAbility to travel for business, project, and issues approximately up to 25% of time.Other duties and projects, as assignedEducation and Experience:BS in EngineeringMinimum of five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industryPharmaceutical or combination product experience preferredKnowledge and Skills:Knows how products are used and impact the user(s) so that risk can be managed effectivelyApply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)Ability to lead creation of risk management filesAbility to develop solutions with business impactAdvanced statistical and risk assessment techniquesWorking knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologiesAbility to make and present risk-based decisionsStrong interpersonal skillsAbility to analyze and optimize manufacturing and quality systems Product, design & prototypingAbility to create and provide trainin Problem solving abilityAbility to create, review and coordinate test protocols and reportsAbility to generate engineering proposalsOral and written presentation skillsAbility to Lead cross functional teamsUnderstanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 Preferred Qualifications:Quality Engineering Certification (ASQ) or equivalentWhy Join Us?To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit.Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.Required SkillsOptional Skills.Primary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork ShiftSummaryLocation: USA AZ - Tempe HeadquartersType: Full time