Manufacturing quality engineering

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.

Primary Duties, Roles, and/or Authorities)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 lineLeads development of risk assessments and test methodsQuality engineering representation on Product Development 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 submissionsComplies with company procedures and policies, government regulationsAbility to travel for business, project, and issues approximately up to 25% of timeOther duties and projects, as assignedEducation and Experience:BS in EngineeringMinimum of two years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industryKnowledge 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 systemsProduct, design & prototypingAbility to create and provide trainingProblem 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 Preferred Qualifications:Quality Engineering Certification (ASQ) or equivalentElectrical Engineering degreePhysical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.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. To learn more about BD visit.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.Full time