Staff Quality Engineer - Product Development

Job Description 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. Job Description We 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 Responsibilities Technical 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 submissions Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed Leads 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 validation Leads product investigations Ability to make and present risked based decisions Assess product changes against product design Supports translation of design inputs into manufacturing control plans Develop and implement procedures to comply with corporate and industry standards. Coordinates and/or directs all aspects of product development activity related to a product line Leads development of risk assessments and test methods Quality engineering representation on Product Development and Design Review teams Prepare and present project updates and technical discussions Participate in project planning, budgeting, scheduling, and tracking Support internal and external supplier audits Provide support to the regulatory department in writing technical submissions Complies with company procedures and policies, government regulations Actively participates in training and providing input to training of employees on division procedures and policies Ability to travel for business, project, and issues approximately up to 25% of time. Other duties and projects, as assigned Required Education and Experience BS 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 industry Extensive proven understanding of design controls in development stage Pharmaceutical or combination product experience Required Qualifications Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.) Ability to lead creation of risk management files Ability to develop solutions with business impact Advanced statistical and risk assessment techniques Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies Ability to make and present risk-based decisions Strong interpersonal skills Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping Ability to create and provide training Problem solving ability Ability to create, review and coordinate test protocols and reports Ability to generate engineering proposals Oral and written presentation skills Ability to lead cross functional teams Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines Preferred Qualifications Quality Engineering Certification (ASQ) or equivalent Physical 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. 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 Environment While 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 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. Primary Work Location : USA AZ - Tempe Headquarters #J-18808-Ljbffr BD Mexico