BD · 16 hours ago
Senior Engineer – Risk Management
San Diego, CA
Full-time
Remote
Mid, Senior Level
$99K/yr - $163K/yr
5+ years exp
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Responsibilities
Lead remediation efforts for updating risk management documents.
Lead cross functional discussions such as with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented. Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle.
Develop, maintain and execute risk management plans that support product development and ongoing sustaining activities in accordance with BD’s risk management framework.
Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with BD’s quality systems and ensuring compliance with regulatory standards and practices.
Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing BD’s risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with BD’s strategic objectives.
Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.
Identify opportunities for continuous improvement of the Risk Management Process.
Qualification
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Required
Experience in medical device and/or regulated industry (required).
Strong communication skills to relay department and area issues, ensuring clarity and cooperation across BD’s global functional teams.
5+ years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors, with a strong preference for experience at BD or similar organizations.
5+ years leading and applying risk management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.
Preferred
Experience leading remediation efforts is a plus.
Familiarity with risk management activities that support BD's compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience a plus.
Experience with Matlab, Python, JMP/Minitab a plus.
Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), with a master’s degree preferred.
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 (48)
2022 (142)
2021 (217)
2020 (149)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
Leadership Team
Tom Polen
Chairman, CEO and President
Philippe Francois
Senior Vice President, Global Supply Chain
Recent News
GlobeNewswire News Room
2024-11-29
2024-11-24
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