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.

• Have understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.

• Be able to develop and implement quality programs, including tracking, analyzing, reporting, and problem solving.

• Be able to represent the team and design during internal and external audits.

• Be able to plan, control, and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling, and measurement systems

• Multiple years of experience working in a hardware/software design and quality assurance environment

• Demonstrable experience validating hardware in a manufacturing environment

#CLOLI

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

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. 

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift