BD
Staff Design Quality Engineer – BD
Staff Design Quality Engineer to support product and process development within the Infusion Platform for New Product Development. The role ensures quality and regulatory compliance of BD devices from design through market release, involving design control, risk management, post‑market surveillance, audits, and training.
Job Responsibilities
Participate in product design and development activities, providing quality engineering support.
Review and approve design inputs, outputs, verification, and validation plans and reports.
Ensure compliance with design control procedures and medical device regulations (FDA 21 CFR Part 820, ISO 13485).
Contribute to Design History File development and maintenance.
Lead risk management activities, including risk management plans, hazard analyses and FMEA.
Support post‑market surveillance by analyzing complaint data and identifying quality issues.
Participate in root‑cause analysis and CAPA investigations related to design quality.
Support internal and external audits, providing documentation and technical expertise.
Provide guidance and training to engineering teams on design control and risk management.
Act as a mentor to junior quality engineers.
Qualifications
Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field); Master’s degree preferred.
5+ years of experience in Design Quality Engineering within the medical device industry.
Experience with 21 CFR Part 820.30 design controls and ISO 14971 risk management.
Strong understanding of ISO 13485 quality management system requirements.
Experience with design verification and validation, including software, system, and human factors testing.
Experience with requirements decomposition, traceability, and test strategy development.
Knowledge of change impact analysis and regression test scoping methods.
Skills
Excellent analytical and problem‑solving skills.
Strong written and verbal communication and interpersonal skills.
Proficiency in statistical analysis and quality tools.
Ability to interpret and apply complex regulatory requirements.
ASQ certifications (e.g., CQE, CRE) preferred.
Proficiency in relevant software tools (TeamCenter, Polarion, AzureDevOps, PLM systems).
Benefits & Workplace BD prioritizes on‑site collaboration and requires a minimum of 4 days in‑office per week for most roles, while supporting flexibility. Remote or field‑based positions will require a different arrangement. COVID‑19 vaccination may be required for certain roles.
Equal Opportunity Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, 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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Job Responsibilities
Participate in product design and development activities, providing quality engineering support.
Review and approve design inputs, outputs, verification, and validation plans and reports.
Ensure compliance with design control procedures and medical device regulations (FDA 21 CFR Part 820, ISO 13485).
Contribute to Design History File development and maintenance.
Lead risk management activities, including risk management plans, hazard analyses and FMEA.
Support post‑market surveillance by analyzing complaint data and identifying quality issues.
Participate in root‑cause analysis and CAPA investigations related to design quality.
Support internal and external audits, providing documentation and technical expertise.
Provide guidance and training to engineering teams on design control and risk management.
Act as a mentor to junior quality engineers.
Qualifications
Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field); Master’s degree preferred.
5+ years of experience in Design Quality Engineering within the medical device industry.
Experience with 21 CFR Part 820.30 design controls and ISO 14971 risk management.
Strong understanding of ISO 13485 quality management system requirements.
Experience with design verification and validation, including software, system, and human factors testing.
Experience with requirements decomposition, traceability, and test strategy development.
Knowledge of change impact analysis and regression test scoping methods.
Skills
Excellent analytical and problem‑solving skills.
Strong written and verbal communication and interpersonal skills.
Proficiency in statistical analysis and quality tools.
Ability to interpret and apply complex regulatory requirements.
ASQ certifications (e.g., CQE, CRE) preferred.
Proficiency in relevant software tools (TeamCenter, Polarion, AzureDevOps, PLM systems).
Benefits & Workplace BD prioritizes on‑site collaboration and requires a minimum of 4 days in‑office per week for most roles, while supporting flexibility. Remote or field‑based positions will require a different arrangement. COVID‑19 vaccination may be required for certain roles.
Equal Opportunity Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, 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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