BD Nogales Norte · 2 days 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. The Sr. Staff Engineer is responsible for leading and managing all quality activities related to design and development of medical devices, ensuring compliance with quality systems and risk management strategies.
Consumer Goods
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 Nogales Norte
Somos una empresa multinacional dedicada a la manufactura de dispositivos de uso médico a través de los cuales seguimos impulsando el mundo de la salud.
1001-5000 employees
H1B Sponsorship
BD Nogales Norte 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
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Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Late StageCompany data provided by crunchbase