Job Details

Staff Quality Engineer, Risk Management – BD (Tissuemed Ltd)

BD is one of the world's largest medical technology companies dedicated to advancing global health. The Staff Quality Engineer, Risk Management will implement and ensure compliance with risk‑management requirements throughout all phases of the life cycle of BD's dispensing medical devices and solutions.

Responsibilities

• Lead cross‑functional discussions with engineering, design, commercial, and product teams to identify hazards, estimate and evaluate risks, and document controls. Monitor and validate the implementation of risk controls throughout product development and post‑market review.
• Develop, maintain, and execute comprehensive risk‑management files, including Risk Management Plan, Risk Management Report, System Hazard Analysis, Hazard and Harm Analysis, Design FMEA, Process FMEA, and Use FMEA.
• Drive implementation and validation of risk controls across the product lifecycle.
• Lead periodic risk reviews, ensuring documentation aligns with BD's quality systems.
• Facilitate remediation of risk‑management documents and FMEA implementation.
• Support Benefit‑Risk Analysis process and evaluate residual risk to align with BD's strategic objectives.
• Document risk review results and communicate findings to cross‑functional teams.
• Ensure harmonization of risk‑management strategies across projects and life‑cycle stages.
• Identify opportunities for continuous improvement of the risk‑management process.
• Provide ongoing training on risk‑management standards and processes.
• Assist with strategic initiatives and planning.
• Mentor and coach team members and cross‑functional collaborators on risk‑management processes.

Required Qualifications

• Familiarity with risk‑management activities supporting compliance with ISO 14971, ISO 13485, IEC 60601, and IEC 62304.
• Experience in medical device or regulated industry (required).
• Experience managing remediation efforts and implementing SHA and FMEA processes (plus).
• Ability to analyze proprietary risk data and calculate risk probabilities and levels.
• Strong communication skills for cross‑functional collaboration.
• Technical experience with Pyxis or automated dispensing cabinets (preferred).

Minimum Educational Level

• Bachelor of Science in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline) – preferred.
• Quality certifications such as ASQ Certified Quality Engineer, Certified Auditor, or Six Sigma (preferred).

Minimum Experience

• At least 8 years in the medical device, bio‑pharmaceutical, or biotechnology sectors.
• At least 5 years leading and applying risk‑management concepts within medical devices, ensuring patient and customer safety.
• Experience leading risk‑management processes with cross‑functional teams.

Location & Work Arrangements

USA – CA; San Diego, TC Building C&D. A minimum of 4 days per week onsite is required; remote options may vary by role.

Salary Range

$124,700 – $205,800 USD per year.

Equal Opportunity Employer

BD is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, age, sex, national origin, or other protected status.