Controls Engineer

Associate Director Of Market Surveillance (PMS)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.The Associate Director of Market Surveillance (PMS) is responsible for ensuring that the business has a robust PMS that meets/exceeds the applicable regulatory requirements, and most importantly, meets the needs of the Dispensing & Pharmacy Automation business and its customers. This position will report into the VP Quality, Dispensing Solutions & Pharmacy Automation.The candidate will have an established track record of implementing and maintaining a PMS that is compliant, efficient, and effective. This person will be responsible for the PMS processes including complaint intake, complaint investigation, reportability determination, complaint trending, linkage to CAPA, linkage to Risk Management, and complaint closure. This person will also be responsible for integrating Dispensing Solutions and Pharmacy Automation PMS into the larger BD PMS. This person will work collaboratively across functions with Quality, Regulatory Affairs, Medical Affairs, Marketing, R&D, Customer Service and other internal stakeholders to develop, review, approve and submit Post Market Surveillance plans per the Quality Management System.The candidate must have hands on experience designing, implementing, and maintaining a PMS process for Class I/II/III medical devices. Specifically, the candidate must have extensive experience with complaint management, failure investigations and failure trending of medical devices. Failure investigation experience must include development of test methods and management controls for ensuring failure investigations are performed in a compliant manner and are effective in determining the root cause of complaints. Failure trending experience should include implementing processes that provide early warning of failure modes and provide analytics to drive corrective actions and risk assessments. The candidate must have experience with analytical tools and statistical trending of complaint data.The candidate will be expected to have a basic understanding of mechanical, electromechanical, and software systems such that they can manage the complaint investigations of such systems. Expertise in Software Engineering is desirable.The candidate must be able to drive corrective actions using the analysis of complaint data. In this role they will work with their partners in R&D and Operations to establish root causes and corrective actions.The candidate will be expected to interface with customers and address their concerns/questions regarding product complaints. The candidate must have excellent communication and presentation skills and will be expected to champion PMS activities for internal and external audits.The candidate will have direct reports and should have excellent people leadership skills experience leading a team. The leader will be responsible for the performance of the complaint handling unit and help create and maintain all PMS Metrics (e.g. complaint closure time, audit findings).EDUCATION AND EXPERIENCE REQUIREMENTSMinimum of a bachelor's degree in science, engineering, or other relevant discipline, with a minimum of ten years of relevant experience.The ability to make timely critical decisions regarding product quality and/or quality system compliance.An individual in this role must have excellent leadership, communication, organization, and project management skills.Experience designing, implementing, and maintaining a PMS process for Class I/II/III medical devices. The ability to effectively lead teams and influence business/platform leaders.The ability to evolve a quality system towards higher levels of performance, efficiency, and compliance.A strong knowledge of WW medical device regulations.A strong working knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.Knowledge of industry PMS software tools (e.g. Trackwise) is desirable.The candidate must have an expert knowledge of PMS requirements from the FDA QSR, ISO-13485, and EU MDR.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.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.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization's investment in BD University, you will continually level up your tech skills and expertise.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.Primary Work Location USA CA - San Diego TC Bldg C&DSalary Range Information $166,500.00 - $274,800.00