BD · 4 hours ago
Sr. Staff Quality Engineer, Risk Management
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$156K/yr - $257K/yr
10+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The Sr. Staff Quality Engineer will lead and manage quality activities related to the design and development of medical devices, ensuring compliance with quality systems and risk management standards.
Health CareMedical DeviceTechnical Support
Responsibilities
Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements
Ensure cybersecurity are integrated into product design, reviewing software artifacts for compliance and traceability
Engage in design and development activities for both medical and non-medical
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members that share in varying pieces of the risk management lifecycle
Oversee risk management using ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership
Find opportunities for continuous improvement of the Design Control (including Risk Management) Process
Qualification
Required
Bachelor's degree in engineering field and 10 years of Quality, Design Controls, Risk Management, or Software experience within the medical device industry
Working knowledge of IEC 62304 and AAMI TIR57
Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies
Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software verification/validation
Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 62304, TIR 57, IEC 62366, 21 CFR 820.30, HE 75, Human Factors
The position requires strong oral and written communication and interpersonal skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products
Benefits
A valuable, competitive package of compensation and benefits programs
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 Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase