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Senior Staff Software Quality Engineer
role at
BD .
We have an immediate opening for a highly motivated, results-focused professional to join our team as a Senior Staff Quality Engineer. The Quality Engineer’s primary responsibilities are to support new product development activities, maintain compliance with company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings, and prepare reports for key quality metrics.
Please note that this role is in the Quality organization and has no direct responsibility for software testing (V&V).
Business & Product Overview BD’s Pharmacy Automation Central Fill solutions transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation, serving networks of retail pharmacies, hospital systems, care facilities, and mail-order services.
Responsibilities
Serve as the quality cornerstone for multi‑functional design teams, championing excellence in both new product development and sustaining engineering efforts
Orchestrate comprehensive quality strategies throughout the design control lifecycle—from initial planning through verification and validation to risk management and regulatory compliance
Provide expert guidance on quality system implementation, with specialized focus on design controls
Conduct thorough reviews of design documentation, ensuring meticulous compliance with Quality Management System requirements and documentation protocols prior to final approval
Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets
Ensure robust verification and validation protocols that definitively confirm design specifications and requirements
Maintain comprehensive traceability matrices across all design elements, creating a clear line of sight from requirements to implementation
Give vital quality insights during product requirement development, system hazard analysis, and critical design reviews
Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently
Lead sophisticated root cause investigations and structured problem‑solving initiatives for both development and manufacturing challenges
Curate impeccable technical files and Design History Files that withstand regulatory scrutiny
Orchestrate continuous improvement initiatives by facilitating multi‑functional collaboration and innovation
Demonstrate mastery of quality engineering principles, methodologies, and industry standards
Apply comprehensive understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304—with minimal direction
Leverage deep knowledge of software quality assurance throughout the development lifecycle
Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies
Use sophisticated engineering tools including statistical analysis, sampling methodologies, and root cause investigation techniques
Serve as a mentor and knowledge resource for developing quality professionals
Differentiating Qualities
Demonstrated success applying Lean or Six Sigma methodologies to streamline software design control processes, with practical implementation examples
Experience championing cybersecurity initiatives within regulated medical device environments
Consistent track record supporting hardware development and integrating hardware/software systems within design controls frameworks
Great foundation in modern software development methodologies
Experience thriving in iterative development environments such as Scaled Agile Framework (SAFe), particularly with SAFe certifications
Comprehensive understanding of risk management principles and quality‑by‑design approaches
Qualifications
Bachelor’s degree in a relevant engineering field and 15 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls OR
Master’s degree in a relevant engineering field and 10 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
Ability to travel up to 10%
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
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.
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Senior Staff Software Quality Engineer
role at
BD .
We have an immediate opening for a highly motivated, results-focused professional to join our team as a Senior Staff Quality Engineer. The Quality Engineer’s primary responsibilities are to support new product development activities, maintain compliance with company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings, and prepare reports for key quality metrics.
Please note that this role is in the Quality organization and has no direct responsibility for software testing (V&V).
Business & Product Overview BD’s Pharmacy Automation Central Fill solutions transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation, serving networks of retail pharmacies, hospital systems, care facilities, and mail-order services.
Responsibilities
Serve as the quality cornerstone for multi‑functional design teams, championing excellence in both new product development and sustaining engineering efforts
Orchestrate comprehensive quality strategies throughout the design control lifecycle—from initial planning through verification and validation to risk management and regulatory compliance
Provide expert guidance on quality system implementation, with specialized focus on design controls
Conduct thorough reviews of design documentation, ensuring meticulous compliance with Quality Management System requirements and documentation protocols prior to final approval
Partner strategically with program management to synchronize design achievements and enable successful commercial launches across markets
Ensure robust verification and validation protocols that definitively confirm design specifications and requirements
Maintain comprehensive traceability matrices across all design elements, creating a clear line of sight from requirements to implementation
Give vital quality insights during product requirement development, system hazard analysis, and critical design reviews
Build collaborative partnerships across functions to drive consensus and resolve sophisticated challenges efficiently
Lead sophisticated root cause investigations and structured problem‑solving initiatives for both development and manufacturing challenges
Curate impeccable technical files and Design History Files that withstand regulatory scrutiny
Orchestrate continuous improvement initiatives by facilitating multi‑functional collaboration and innovation
Demonstrate mastery of quality engineering principles, methodologies, and industry standards
Apply comprehensive understanding of regulatory frameworks and international standards—including EU MDR 2017/745, ISO 9001, ISO 14971, and IEC 62304—with minimal direction
Leverage deep knowledge of software quality assurance throughout the development lifecycle
Proactively identify potential risks and collaborate with program teams to document and implement effective mitigation strategies
Use sophisticated engineering tools including statistical analysis, sampling methodologies, and root cause investigation techniques
Serve as a mentor and knowledge resource for developing quality professionals
Differentiating Qualities
Demonstrated success applying Lean or Six Sigma methodologies to streamline software design control processes, with practical implementation examples
Experience championing cybersecurity initiatives within regulated medical device environments
Consistent track record supporting hardware development and integrating hardware/software systems within design controls frameworks
Great foundation in modern software development methodologies
Experience thriving in iterative development environments such as Scaled Agile Framework (SAFe), particularly with SAFe certifications
Comprehensive understanding of risk management principles and quality‑by‑design approaches
Qualifications
Bachelor’s degree in a relevant engineering field and 15 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls OR
Master’s degree in a relevant engineering field and 10 years’ experience with emphasis on R&D development, Quality Engineering and Design Controls
Ability to travel up to 10%
Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
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.
#J-18808-Ljbffr