BD Mexico
Staff Quality Engineer, Risk Management
BD Mexico, San Diego, California, United States, 92189
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. Job Description: The Staff Engineer – Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions. They will lead multi-functional teams during the design and development and post-market risk management reviews to ensure that all necessary risk management activities are driven in accordance with the quality system. This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability. The role will lead and coach multi-functional teams on risk management processes that supports BD's commitment to innovation and patient safety. Responsibilities
Lead cross functional discussions with engineering, design, commercial, and product teams to identify hazards and ensure risks are estimated, evaluated, controlled, and documented. Monitor risk controls and verify effectiveness throughout the product life cycle. Develop, maintain, and execute comprehensive risk management files (e.g., Risk Management Plan, Risk Management Report, Risk Reviews, SHA, HHA, dFMEA, pFMEA, uFMEA). Drive implementation and validation of risk controls across the product lifecycle. Lead periodic risk reviews and ensure documentation aligns with BD’s quality systems. Develop and maintain risk management plans to support product development and sustaining activities in BD’s risk management framework. Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and regulatory compliance. Lead remediation efforts for updating risk management documents and the FMEA process. Evaluate estimated risk and acceptability, document risk controls when risks are not acceptable. Support Benefit-Risk Analysis and evaluate overall residual risk aligned with BD’s objectives. Perform and document Risk Reviews to communicate results to cross-functional teams. Harmonize risk management strategies across projects and lifecycle by communicating with Risk team members. Identify opportunities for continuous improvement of the Risk Management Process. Provide ongoing training on standards/processes to other associates or functions as needed. Assist with strategic initiatives and planning. Mentor and coach other team members on risk management processes. Required Qualifications
Knowledge, Skills & Abilities
Familiarity with risk management activities supporting regulatory compliance (ISO 14971, ISO 13485). IEC 60601 and IEC 62304 experience a plus. Experience in medical device and/or regulated industry (required). Experience with remediation, SHA, and FMEA processes for medical devices is a plus. Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels. Strong communication skills to relay issues clearly across global teams. Technical experience with Pyxis or automated dispensing cabinets (preferred). Minimum Educational Level
Bachelor of Science in engineering (Mechanical, Electrical, Materials, Biomedical, or related), preferred. Quality certifications such as ASQ Certified Quality Engineer, Certified Auditor, Six Sigma credentials preferred. Minimum Experience
Minimum 8 years in medical device, bio-pharmaceutical, or biotechnology sectors. Minimum 5 years leading risk management concepts specifically within medical devices for patient and customer safety. Experience leading and coordinating multi-functional teams on risk management processes. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office per week is required to maintain our culture, with flexibility as applicable. Remote or field-based positions will have different workplace arrangements indicated in the job posting. For certain roles at BD, employment is contingent upon sufficient proof of full COVID-19 vaccination. In some locations, testing may be available 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 values your opinions and contributions and encourages you to bring your authentic self to work. We help each other be great, we do what’s right, we hold each other accountable, and we learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture and understand the human story behind our work. We welcome people with imagination and drive to reinvent the future of health. You’ll discover a culture where you can learn, grow, and thrive while helping to make the world a better place. To learn more about BD visit https://bd.com/careers Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Primary Work Location USA CA - San Diego TC Bldg C&D Work Shift NA (United States of America) At BD, we are committed to investing in our associates’ well-being and development, offering rewards and recognition opportunities that promote a performance-based culture. Details are available on our Careers Site under Our Commitment to You. Salary Range Information $124,700.00 - $205,800.00 USD Annual Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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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. Job Description: The Staff Engineer – Risk Management is responsible for implementing and ensuring compliance with risk management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions. They will lead multi-functional teams during the design and development and post-market risk management reviews to ensure that all necessary risk management activities are driven in accordance with the quality system. This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability. The role will lead and coach multi-functional teams on risk management processes that supports BD's commitment to innovation and patient safety. Responsibilities
Lead cross functional discussions with engineering, design, commercial, and product teams to identify hazards and ensure risks are estimated, evaluated, controlled, and documented. Monitor risk controls and verify effectiveness throughout the product life cycle. Develop, maintain, and execute comprehensive risk management files (e.g., Risk Management Plan, Risk Management Report, Risk Reviews, SHA, HHA, dFMEA, pFMEA, uFMEA). Drive implementation and validation of risk controls across the product lifecycle. Lead periodic risk reviews and ensure documentation aligns with BD’s quality systems. Develop and maintain risk management plans to support product development and sustaining activities in BD’s risk management framework. Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and regulatory compliance. Lead remediation efforts for updating risk management documents and the FMEA process. Evaluate estimated risk and acceptability, document risk controls when risks are not acceptable. Support Benefit-Risk Analysis and evaluate overall residual risk aligned with BD’s objectives. Perform and document Risk Reviews to communicate results to cross-functional teams. Harmonize risk management strategies across projects and lifecycle by communicating with Risk team members. Identify opportunities for continuous improvement of the Risk Management Process. Provide ongoing training on standards/processes to other associates or functions as needed. Assist with strategic initiatives and planning. Mentor and coach other team members on risk management processes. Required Qualifications
Knowledge, Skills & Abilities
Familiarity with risk management activities supporting regulatory compliance (ISO 14971, ISO 13485). IEC 60601 and IEC 62304 experience a plus. Experience in medical device and/or regulated industry (required). Experience with remediation, SHA, and FMEA processes for medical devices is a plus. Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels. Strong communication skills to relay issues clearly across global teams. Technical experience with Pyxis or automated dispensing cabinets (preferred). Minimum Educational Level
Bachelor of Science in engineering (Mechanical, Electrical, Materials, Biomedical, or related), preferred. Quality certifications such as ASQ Certified Quality Engineer, Certified Auditor, Six Sigma credentials preferred. Minimum Experience
Minimum 8 years in medical device, bio-pharmaceutical, or biotechnology sectors. Minimum 5 years leading risk management concepts specifically within medical devices for patient and customer safety. Experience leading and coordinating multi-functional teams on risk management processes. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving. For most roles, a minimum of 4 days in-office per week is required to maintain our culture, with flexibility as applicable. Remote or field-based positions will have different workplace arrangements indicated in the job posting. For certain roles at BD, employment is contingent upon sufficient proof of full COVID-19 vaccination. In some locations, testing may be available 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 values your opinions and contributions and encourages you to bring your authentic self to work. We help each other be great, we do what’s right, we hold each other accountable, and we learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture and understand the human story behind our work. We welcome people with imagination and drive to reinvent the future of health. You’ll discover a culture where you can learn, grow, and thrive while helping to make the world a better place. To learn more about BD visit https://bd.com/careers Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Primary Work Location USA CA - San Diego TC Bldg C&D Work Shift NA (United States of America) At BD, we are committed to investing in our associates’ well-being and development, offering rewards and recognition opportunities that promote a performance-based culture. Details are available on our Careers Site under Our Commitment to You. Salary Range Information $124,700.00 - $205,800.00 USD Annual Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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