BD (Tissuemed Ltd)
Staff Quality Engineer I - Software
Accountable to participate on project teams and manage Quality function deliverables for new and transferred products, ensuring regulatory compliance and robust product/process design for software products.
Job Description Now we are the makers of possibility. 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.
Responsibilities
Project Team Leadership – Serve as the quality champion across multiple development teams, bringing expertise to new product creation and manufacturing transfer initiatives.
Regulatory Compliance Mastery – Ensure all projects meet or exceed customer expectations while navigating complex regulatory frameworks including:
FDA 21CFR820 Quality System Regulation
21CFR11 Electronic Records requirements
ISO 13485 Medical Device Quality Management
ISO 14971 Risk Management protocols
IEC 62304 Software Lifecycle standards
European directives IVDD 98/79/EEC and MDD 93/42/EEC
Computer System Validation Leadership – Spearhead validation activities and compliance assessments, ensuring data integrity across all platforms.
Software Development Lifecycle Excellence – Drive comprehensive quality throughout the entire development process: planning, design input/output, design history file documentation, design transfer processes, change and risk management, and design reviews for both application and embedded software.
Documentation Authority – Review and approve critical product documentation, technical drawings, and verification/validation processes with expert precision.
Data‑Driven Problem Solving – Apply sophisticated statistical tools to analyze performance data, identify root causes, and implement effective resolutions.
Quality Strategy Development – Create and maintain innovative strategies to enhance overall software quality, test coverage, and system performance metrics.
Quality Engineering Leadership – Provide both strategic vision and tactical guidance based on deep understanding of 21 CFR Part 820 and ISO Requirements.
Design Review Ownership – Lead and facilitate comprehensive design and functional review processes specifically for software products.
Cross‑Functional Collaboration – Partner with Manufacturing and R&D teams to drive software product improvements and monitor measurable quality enhancements.
Compliance Assurance – Ensure all divisional and departmental policies, procedures, and practices maintain regulatory compliance.
New Product Development Representation – Be the voice of Quality on core development and technology transfer teams.
GPDS Team Contribution – Deliver assigned software development deliverables including requirements documentation, development planning, risk management, and verification/validation.
Continuous Improvement – Lead remediation efforts for software‑related audit findings and Corrective and Preventive Actions (CAPAs).
Required Qualifications
• Bachelor’s degree in Electrical, Mechanical, Software, Biomedical Engineering or other relevant technical area and 9 years of experience, where 6 of those years are progressive experience in software development or lifecycle management.
• MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management.
• Demonstrated expertise typically evidenced through certification in at least one of the following: ASQ‑CQA/CQE/CSQE, AAMI, AOAC, Six Sigma, RAPS or a Company certification such as Green Belt, Black Belt, IGQA auditor, etc.
Skills
Ability to effectively manage multiple tasks and lead execution of change management plans.
Ability and skill to lead or manage the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, Six Sigma root‑cause analysis tools and project management techniques.
Effective written communication skills that ensure clarity, accuracy and consideration of the audience.
Strong speaking skills with clarity and expression in a variety of settings, including one‑on‑one interactions, group meetings, and formal presentations.
Active listening skills, understanding associates, managers, peers and customers when making decisions and solving problems.
Analytical skills to diagnose using systematic tools such as Six Sigma, root cause, failure analysis and risk assessment.
Conflict resolution skills to drive results through working teams.
Working knowledge of FDA 21 CFR 820 and ISO standards.
Remote/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.
Salary Range: $113,400.00 - $186,900.00 USD Annual
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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
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Accountable to participate on project teams and manage Quality function deliverables for new and transferred products, ensuring regulatory compliance and robust product/process design for software products.
Job Description Now we are the makers of possibility. 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.
Responsibilities
Project Team Leadership – Serve as the quality champion across multiple development teams, bringing expertise to new product creation and manufacturing transfer initiatives.
Regulatory Compliance Mastery – Ensure all projects meet or exceed customer expectations while navigating complex regulatory frameworks including:
FDA 21CFR820 Quality System Regulation
21CFR11 Electronic Records requirements
ISO 13485 Medical Device Quality Management
ISO 14971 Risk Management protocols
IEC 62304 Software Lifecycle standards
European directives IVDD 98/79/EEC and MDD 93/42/EEC
Computer System Validation Leadership – Spearhead validation activities and compliance assessments, ensuring data integrity across all platforms.
Software Development Lifecycle Excellence – Drive comprehensive quality throughout the entire development process: planning, design input/output, design history file documentation, design transfer processes, change and risk management, and design reviews for both application and embedded software.
Documentation Authority – Review and approve critical product documentation, technical drawings, and verification/validation processes with expert precision.
Data‑Driven Problem Solving – Apply sophisticated statistical tools to analyze performance data, identify root causes, and implement effective resolutions.
Quality Strategy Development – Create and maintain innovative strategies to enhance overall software quality, test coverage, and system performance metrics.
Quality Engineering Leadership – Provide both strategic vision and tactical guidance based on deep understanding of 21 CFR Part 820 and ISO Requirements.
Design Review Ownership – Lead and facilitate comprehensive design and functional review processes specifically for software products.
Cross‑Functional Collaboration – Partner with Manufacturing and R&D teams to drive software product improvements and monitor measurable quality enhancements.
Compliance Assurance – Ensure all divisional and departmental policies, procedures, and practices maintain regulatory compliance.
New Product Development Representation – Be the voice of Quality on core development and technology transfer teams.
GPDS Team Contribution – Deliver assigned software development deliverables including requirements documentation, development planning, risk management, and verification/validation.
Continuous Improvement – Lead remediation efforts for software‑related audit findings and Corrective and Preventive Actions (CAPAs).
Required Qualifications
• Bachelor’s degree in Electrical, Mechanical, Software, Biomedical Engineering or other relevant technical area and 9 years of experience, where 6 of those years are progressive experience in software development or lifecycle management.
• MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management.
• Demonstrated expertise typically evidenced through certification in at least one of the following: ASQ‑CQA/CQE/CSQE, AAMI, AOAC, Six Sigma, RAPS or a Company certification such as Green Belt, Black Belt, IGQA auditor, etc.
Skills
Ability to effectively manage multiple tasks and lead execution of change management plans.
Ability and skill to lead or manage the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, Six Sigma root‑cause analysis tools and project management techniques.
Effective written communication skills that ensure clarity, accuracy and consideration of the audience.
Strong speaking skills with clarity and expression in a variety of settings, including one‑on‑one interactions, group meetings, and formal presentations.
Active listening skills, understanding associates, managers, peers and customers when making decisions and solving problems.
Analytical skills to diagnose using systematic tools such as Six Sigma, root cause, failure analysis and risk assessment.
Conflict resolution skills to drive results through working teams.
Working knowledge of FDA 21 CFR 820 and ISO standards.
Remote/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.
Salary Range: $113,400.00 - $186,900.00 USD Annual
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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally‑protected characteristics.
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