Senior Principal Quality Engineer

Job Description Summary Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and BD systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. 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 healthu2122 is our Purpose, and itu2019s no small feat. It takes the imagination and passion of all of usu2014from design and engineering to the manufacturing and marketing of our billions of MedTech products per yearu2014to 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 youu2019ll be supported to learn, grow and become your best self. Become a maker of possible with us. Key Responsibilities: + Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineeringprinciples; analyze results, make recommendations and develop reports. + Own and close complaint Engineering investigations for BD electronic complaints. + Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. find opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. + Develop, update, and maintain technical content of risk management files for NPD and existing products. + Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes. + Support product upgrading and reworking tasks as needed as Quality Engineer. + Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. + Train, coach, and guide lower-level employees on routine procedures + Other incidental duties assigned by Leadership Education and Experience: + Bachelor's Degree in Engineering or Scientific field + Minimum of 8 years experience, including strong electromechanical medical device experience + CAPA and complaints management experience required + Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills + Strict attention to detail Preferred Qualifications: + ASQ Certified Quality Engineer (CQE) + Considers the cause and effect of activities + Makes decisions in the face of different alternatives and without formulas or guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment. + Determines or effectively recommends course of action after considering potential risks of alternatives by comparing and evaluating possible courses of action after considering various possibilities + Works independently without close supervision + Applies their knowledge in following procedures or in determining procedures to follow or determining whether specified standards are met + Proven expertise in usage of MS Office Suite + Ability to read and interpret drawings + Proven expertise in statistical techniques + Ability to translate complex and technical information to all levels of the organizations + Recognized as an expert in own area within the organization + Expert knowledge and understanding and knowledge ofprinciples, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge) + Expertise of Six Sigma concepts with the ability to lead projects applying theseprinciples + Expertise in applying Quality Engineering concepts (e.g., CQE body of knowledge) with the ability to lead projects using theseprinciples + Advanced problem-solving, organizational, analytical and critical thinking skills + Expert understanding of processes and equipment used in assigned work + Strong leadership skills and ability to influence change and challenge status quo with respect to opportunities for improvement. + Ability to interact professionally with all organizational levels. + Ability to manage competing priorities in a fast paced environment 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 Companyu2019s 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 BDu2019s 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. Itu2019s also a place where we help each other be great, we do whatu2019s 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, youu2019ll 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. Required Skills Optional Skills . Primary Work Location USA CA - Irvine Laguna Canyon Additional Locations Work Shift NA (United States of America) At BD, we are strongly committed to investing in our associatesu2014their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (. Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associatesu2019 progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $124,700.00 - $205,800.00 USD Annual 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.

Created: 2026-01-22