Staff Quality Engineer - Product Development

Job Description SummaryThis 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.Job DescriptionWe are the makers of possible BD 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.We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.Job ResponsibilitiesTechnical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices.The ability to create, support, review chemistry, manufacturing, and controls device submissionsParticipates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completedLeads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)Leads component qualifications, design validation, design verification, drug stability 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 and 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 submissionsComplies with company procedures and policies, government regulationsActively participates in training and providing input to training of employees on division procedures and policiesAbility to travel for business, project, and issues approximately up to 25% of time.Other duties and projects, as assignedRequired Education And ExperienceBS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industryExtensive proven understanding of design controls in development stagePharmaceutical or combination product experienceRequired QualificationsApply 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, 21 CFR 210/211/820 , ICH Guidelines Preferred QualificationsQuality Engineering Certification (ASQ) or equivalentPhysical DemandsWhile 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. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.Work EnvironmentWhile performing the duties of this job, the employee may be in an open cubicle environment.Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.Travel required: ≤25%At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.To learn more about BD visit https://bd.com/careers (opens in new window)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.#cloliRequired SkillsOptional SkillsPrimary Work LocationUSA AZ - Tempe HeadquartersAdditional LocationsWork Shift