BD (Tissuemed Ltd)
Staff Design Quality Engineer
BD (Tissuemed Ltd), San Diego, California, United States, 92189
Job Summary
Staff Design Quality Engineer supporting product and process development within the Infusion Platform for New Product Development, ensuring quality and regulatory compliance throughout the product lifecycle.
Job Responsibilities
Actively participate in product design and development activities, providing quality engineering support and guidance.
Review and approve design inputs, design outputs, verification and validation plans and reports.
Ensure compliance with design control procedures, FDA 21 CFR Part 820 and ISO 13485 regulations.
Contribute to the development and maintenance of Design History Files (DHFs).
Lead risk management activities, including risk plans, hazard analyses and FMEAs.
Implement risk mitigation strategies and verify their effectiveness.
Support post‑market surveillance; analyze complaint data and identify quality issues.
Participate in root cause analysis and CAPA investigations related to design quality.
Verify effectiveness of CAPA actions.
Support internal and external audits (FDA, ISO) by providing documentation and expertise.
Provide guidance and training to engineering teams on design control, risk management and quality system requirements.
Act as a mentor to junior quality engineers.
Job Qualifications
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical or related field) required; Master's preferred.
5+ years of experience in Design Quality Engineering within the medical device industry.
Demonstrated experience with design controls (21 CFR Part 820.30) and risk management (ISO 14971).
Strong understanding of ISO 13485 quality management system requirements.
Experience with Design Verification and Validation activities, including software, system and human factors testing.
Experience in requirements decomposition, traceability and test strategy development.
Understanding of change impact analysis and regression test scoping methods.
Proficiency in statistical analysis and quality tools.
Expertise in interpreting and applying complex regulatory requirements.
ASQ certifications (CQE, CRE) preferred.
Proficiency in relevant software tools (TeamCenter, Polarion, AzureDevOps, PLM systems).
Workplace We prioritize on‑site collaboration; most roles require a minimum of four days per week in the office, with flexibility for remote or field‑based arrangements as indicated in the posting.
Employment is contingent upon proof of COVID‑19 vaccination.
EEO Statement 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.
Location USA CA – San Diego TC Bldg C&D
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Medical Equipment Manufacturing
Salary Range $124,700.00 – $205,800.00 USD Annual
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Job Responsibilities
Actively participate in product design and development activities, providing quality engineering support and guidance.
Review and approve design inputs, design outputs, verification and validation plans and reports.
Ensure compliance with design control procedures, FDA 21 CFR Part 820 and ISO 13485 regulations.
Contribute to the development and maintenance of Design History Files (DHFs).
Lead risk management activities, including risk plans, hazard analyses and FMEAs.
Implement risk mitigation strategies and verify their effectiveness.
Support post‑market surveillance; analyze complaint data and identify quality issues.
Participate in root cause analysis and CAPA investigations related to design quality.
Verify effectiveness of CAPA actions.
Support internal and external audits (FDA, ISO) by providing documentation and expertise.
Provide guidance and training to engineering teams on design control, risk management and quality system requirements.
Act as a mentor to junior quality engineers.
Job Qualifications
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical or related field) required; Master's preferred.
5+ years of experience in Design Quality Engineering within the medical device industry.
Demonstrated experience with design controls (21 CFR Part 820.30) and risk management (ISO 14971).
Strong understanding of ISO 13485 quality management system requirements.
Experience with Design Verification and Validation activities, including software, system and human factors testing.
Experience in requirements decomposition, traceability and test strategy development.
Understanding of change impact analysis and regression test scoping methods.
Proficiency in statistical analysis and quality tools.
Expertise in interpreting and applying complex regulatory requirements.
ASQ certifications (CQE, CRE) preferred.
Proficiency in relevant software tools (TeamCenter, Polarion, AzureDevOps, PLM systems).
Workplace We prioritize on‑site collaboration; most roles require a minimum of four days per week in the office, with flexibility for remote or field‑based arrangements as indicated in the posting.
Employment is contingent upon proof of COVID‑19 vaccination.
EEO Statement 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.
Location USA CA – San Diego TC Bldg C&D
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industry Medical Equipment Manufacturing
Salary Range $124,700.00 – $205,800.00 USD Annual
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