BD
Staff Quality Engineer, Risk Management
– BD
BD
is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose. We bring imagination and passion from design, engineering, manufacturing and marketing to transform the impossible into innovative solutions.
Job Description The Staff Quality 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, development and post‑market risk management reviews, ensuring all necessary risk management activities follow the quality system and protect patient safety.
Responsibilities
Lead cross‑functional discussions to identify hazards, estimate, evaluate, control, and document risks; monitor risk controls and validate effectiveness throughout the product life cycle.
Develop, maintain, and execute comprehensive risk management files, including Risk Management Plan, Risk Management Report, Risk Reviews, SHA, HHA, dFMEA, pFMEA, uFMEA.
Drive implementation and validation of risk controls throughout the product lifecycle.
Lead periodic risk reviews and ensure documentation aligns with BD’s quality systems.
Maintain and execute risk management plans that support product development and sustaining activities per BD’s framework.
Lead periodic reviews of the risk management process and quality system deliverables, documenting decisions and actions per regulatory standards.
Lead remediation of updated risk management documents and implementation of the FMEA process.
Evaluate estimated risk and acceptability using 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 evaluation of residual risk, ensuring alignment with BD’s strategic objectives.
Perform and document risk reviews, communicating results to cross‑functional teams.
Ensure harmonization of risk‑management strategies across projects and lifecycle by communicating with other risk team members.
Identify opportunities for continuous improvement of the risk‑management process.
Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
Assist with strategic initiatives and planning.
Mentor and coach other members on the team and cross‑functional teams on risk‑management processes.
Required Qualifications Knowledge, Skills & Abilities:
Familiarity with risk‑management activities supporting BD’s compliance with international regulatory bodies, including ISO 14971, ISO 13485; IEC 60601 and IEC 62304 experience is a plus.
Experience in medical device and/or regulated industry (required).
Experience with remediation efforts and SHA, FMEA process implementation with medical devices is a plus.
Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels effectively.
Strong communication skills to relay department and area issues, ensuring clarity and cooperation across BD’s global functional teams.
Technical experience with Pyxis or automated dispensing cabinets (preferred).
Minimum Educational Level
Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), preferred.
Quality certifications relevant to BD such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.
Minimum Experience
Minimum 8 years within the medical device, bio‑pharmaceutical, or biotechnology sectors.
Minimum 5 years leading and applying risk‑management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.
Experience leading team members on risk‑management processes and multi‑functional teams.
BD prioritizes on‑site collaboration with a minimum of 4 days in-office per week to maintain culture and operations. Remote or field‑based positions will have different workplace arrangements indicated in the job posting.
For certain roles, employment is contingent upon the Company’s receipt of sufficient proof of full vaccination against COVID‑19. In some locations, testing may be available or required. Requests for accommodation are considered pursuant to applicable law.
Why Join Us? A career at BD values your opinions and contributions, encourages authenticity, and fosters a culture of accountability, learning and improvement. We help each other to be great and to reinvent the future of health. You can learn, grow, thrive and make a difference in the world.
To learn more about BD: https://bd.com/careers
Equal Opportunity Employer
– Becton, Dickinson, and Company evaluates applicants without regard to protected characteristics such as race, color, religion, age, sex, and others in accordance with applicable law.
Salary Range $124,700.00 – $205,800.00 USD Annual
Location:
San Diego, CA – TC Bldg C&D, USA
#J-18808-Ljbffr
– BD
BD
is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose. We bring imagination and passion from design, engineering, manufacturing and marketing to transform the impossible into innovative solutions.
Job Description The Staff Quality 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, development and post‑market risk management reviews, ensuring all necessary risk management activities follow the quality system and protect patient safety.
Responsibilities
Lead cross‑functional discussions to identify hazards, estimate, evaluate, control, and document risks; monitor risk controls and validate effectiveness throughout the product life cycle.
Develop, maintain, and execute comprehensive risk management files, including Risk Management Plan, Risk Management Report, Risk Reviews, SHA, HHA, dFMEA, pFMEA, uFMEA.
Drive implementation and validation of risk controls throughout the product lifecycle.
Lead periodic risk reviews and ensure documentation aligns with BD’s quality systems.
Maintain and execute risk management plans that support product development and sustaining activities per BD’s framework.
Lead periodic reviews of the risk management process and quality system deliverables, documenting decisions and actions per regulatory standards.
Lead remediation of updated risk management documents and implementation of the FMEA process.
Evaluate estimated risk and acceptability using 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 evaluation of residual risk, ensuring alignment with BD’s strategic objectives.
Perform and document risk reviews, communicating results to cross‑functional teams.
Ensure harmonization of risk‑management strategies across projects and lifecycle by communicating with other risk team members.
Identify opportunities for continuous improvement of the risk‑management process.
Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
Assist with strategic initiatives and planning.
Mentor and coach other members on the team and cross‑functional teams on risk‑management processes.
Required Qualifications Knowledge, Skills & Abilities:
Familiarity with risk‑management activities supporting BD’s compliance with international regulatory bodies, including ISO 14971, ISO 13485; IEC 60601 and IEC 62304 experience is a plus.
Experience in medical device and/or regulated industry (required).
Experience with remediation efforts and SHA, FMEA process implementation with medical devices is a plus.
Ability to analyze data from BD’s proprietary sources to calculate risk probabilities and levels effectively.
Strong communication skills to relay department and area issues, ensuring clarity and cooperation across BD’s global functional teams.
Technical experience with Pyxis or automated dispensing cabinets (preferred).
Minimum Educational Level
Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), preferred.
Quality certifications relevant to BD such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.
Minimum Experience
Minimum 8 years within the medical device, bio‑pharmaceutical, or biotechnology sectors.
Minimum 5 years leading and applying risk‑management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.
Experience leading team members on risk‑management processes and multi‑functional teams.
BD prioritizes on‑site collaboration with a minimum of 4 days in-office per week to maintain culture and operations. Remote or field‑based positions will have different workplace arrangements indicated in the job posting.
For certain roles, employment is contingent upon the Company’s receipt of sufficient proof of full vaccination against COVID‑19. In some locations, testing may be available or required. Requests for accommodation are considered pursuant to applicable law.
Why Join Us? A career at BD values your opinions and contributions, encourages authenticity, and fosters a culture of accountability, learning and improvement. We help each other to be great and to reinvent the future of health. You can learn, grow, thrive and make a difference in the world.
To learn more about BD: https://bd.com/careers
Equal Opportunity Employer
– Becton, Dickinson, and Company evaluates applicants without regard to protected characteristics such as race, color, religion, age, sex, and others in accordance with applicable law.
Salary Range $124,700.00 – $205,800.00 USD Annual
Location:
San Diego, CA – TC Bldg C&D, USA
#J-18808-Ljbffr