Staff Quality Engineer

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.

Position Overview :

We are seeking an accomplished and driven Hardware Quality Engineer to lead our core quality team for Pharmacy Automation Central Fill solutions. This individual will be responsible for ensuring that all hardware systems and components meet rigorous compliance engineering standards and achieve safety certification for high-volume central fill pharmacy sites.

Business & Product Overview :

BD’s Pharmacy Automation Central Fill solutions are designed to transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation. These centralized facilities serve networks of retail pharmacies, hospital systems, care facilities, and mail-order services, enabling efficient medication distribution from a single location.

Key Responsibilities :

Serve as the core team quality lead for hardware design and development projects, including new product introductions and sustaining engineering efforts.

Oversee all quality aspects of the hardware design control process : quality planning, verification and validation (V&V), risk management, and regulatory compliance.

Provide expert guidance on compliance engineering standards (e.g., UL, IEC, ISO 60601, ISO 14971, and EU MDR 2017 / 745) and safety certification requirements for central fill automation.

Lead the preparation and maintenance of technical files, Design History Files (DHFs), and documentation required for regulatory submissions and audits.

Collaborate closely with cross-functional teams (R&D, Regulatory, Manufacturing, and Program Management) to ensure hardware deliverables meet internal and external standards.

Drive root cause analysis and structured problem-solving for hardware failures and nonconformities.

Mentor and coach team members, fostering a culture of quality, safety, and continuous improvement.

Actively participate in product risk assessments, hazard analyses, and design reviews.

Ensure traceability and completeness of all hardware design artifacts and safety documentation.

Stay current with evolving global safety and compliance standards relevant to central fill pharmacy automation.

Required Qualifications :

• Bachelor’s degree in Electrical, Mechanical, or Systems Engineering (or related field)
• 10 years of experience in hardware quality engineering, with a strong focus on compliance and safety certification in regulated environments.
• Experience leading teams through hardware safety certification processes (UL, IEC, ISO, etc.).
• Experience with regulatory and international standards, including EU MDR 2017 / 745, ISO 9001, ISO 14971, and relevant hardware safety standards.

Preferred Qualifications :

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.