Job Description Summary

As directed by the Sr. Quality Manager, the Staff Quality Engineer within the BD Medication Delivery Solutions (BD MDS) team is responsible for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

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.

You are responsible for

• Ensuring that appropriate quality plans are made that include all stages of the life cycle of the product and supports quality plan design with an emphasis on design controls.

• Providing effective oversight of the execution of the Quality Plan, and Risk Management activities, and partnering with the design team to successfully deliver product/system lifecycle with an emphasis on electromechanical hardware and software components standards such IEC 60601 and IEC 62304.

• Identify electromechanical hardware and software quality challenges and software quality improvement opportunities.

• Provide coordination and guidance to cross functional teams to ensure software quality objectives are met per IEC 62304 and local procedures for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices

• Provide coordination and guidance to cross functional teams to compliance with IEC 60601 basic safety and other applicable requirements during design and testing.

• Reviews and approves project documentation including Software Development Plans, Software Requirements Specifications, Software Design Documents, Software Test Plans/Protocols/Reports

• Performing independent technical assessment on product quality performance and post-market product quality analysis

• Leading or supporting quality related problem solving and root cause analysis during design and manufacturing

• Acting as the focal point that is accountable and responsible to ensure that the electromechanical and software based design meets quality and compliance standards for every milestone

• Function as a local subject matter expert on electromechanical hardware validation techniques and management of electronic records and signatures.

• Validating key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs

• Provide leadership and oversight to ensure Quality Management System compliance

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in mechanical, Electrical, Computer science, Biomedical or similar or equivalent experience in medical device industry.

• 8+ years’ experience with a medical device company delivering complex electromechanical software driven instruments or devices, particularly in medical device software development or quality assurance in accordance with IEC 62304 Class B and C, and TIR45:2023 agile practices

• Significant depth of experience in working in quality systems compliant with 21CFR, ISO 13485/14971, IEC 62304, IEC 60601 and AAMI TIR45:2023, and FDA’s guidance of Cybersecurity in Medical Devices. Working knowledge of software development methodologies including maturity models, SDLC deliverables and software qualification, and agile practices.

• ASQ certified Quality Engineer preferred

• Have an understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics, customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics.