BD · 2 months ago
Staff Hardware Quality Engineer
USA NC - Durham - Roche Drive
Full-time
Onsite
Lead/Staff
10+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health solutions. The Staff Hardware Quality Engineer will lead the core quality team for Pharmacy Automation Central Fill solutions, ensuring compliance with engineering standards and safety certification for hardware systems.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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
Experience with lean or six sigma methodologies applied to hardware quality processes
Prior success in achieving safety certifications for large-scale automation or central fill systems
ASQ Certified Quality Engineer (CQE) or equivalent certification
Experience supporting hardware/software integrated systems and working with central fill or automation technologies
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
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