Sr. Design Quality Engineer

Senior Design Quality Engineer

Join our team as a Senior Design Quality Engineer where you'll be the guardian of quality for our critical product family, directly protecting patient safety and business risk while driving innovation in medical device development!

You'll work at the intersection of innovation and compliance, ensuring every change we make is robust, validated, and protects both our patients and our business.

Responsibilities:

• Quality Leadership Across the Product Lifecycle: Serve as the Quality Assurance expert for your entire product line, owning Design Control, Document Control, and QA processes from concept to commercialization
• Strategic Partnership: Collaborate with contract manufacturers and internal plants to seamlessly implement changes while maintaining the highest quality standards
• Proactive Risk Management: Monitor complaint trends like a detective, identifying performance drift before it becomes a problem and executing swift corrective actions
• Subject Matter Authority: Be the go-to resource for cross-functional teams in Engineering, Operations, and supplier management
• Champion Design Control Excellence: Serve as the Quality Representative on Project Teams, ensuring Design Control principles are woven into every Product and Process Change and New Product Development initiative
• Lead Quality Initiatives: Provide QA leadership for Project Teams and the Quality Department.
• Master Documentation: Build, review, and approve critical Quality System Documents including CAPAs and Audit reports
• Craft Compliance Artifacts: Create and approve Design History Files, ensuring every product decision is documented and defensible
• Validate Everything: Develop, review, and approve Protocols for Process and Product Validations, Stability studies, and Software Validation documents
• Assess and Mitigate Risk: Create comprehensive Risk Assessments using FMEA, FMECA, and FTA methodologies
• Develop Talent: Mentor staff and provide supervision to technicians and engineers, building the next generation of quality professionals
• Drive Continuous Improvement: Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans that stick
• Audit with Authority: Conduct Internal and Supplier Quality System Audits to ensure compliance across the supply chain
• Stay Ahead of the Curve: Maintain active membership in trade and professional organizations, bringing state-of-the-art industry standards back to the team
• Investigate and Resolve: Perform thorough Complaint reviews and investigations, getting to the root cause quickly
• Track Success Metrics: Monitor and trend Quality Indicators to demonstrate continuous improvement
• Collaborate Across Sites: Work seamlessly with manufacturing facilities and other Division Facilities to ensure quality consistency
• Chair Critical Reviews: Serve as Independent QA Reviewer and Chairperson for Design Reviews, making the tough calls when needed

You'll be working on critical products that directly impact patient lives. Every validation you approve, every risk assessment you complete, and every trend you identify make a difference.

This position requires someone who can balance technical expertise with leadership presence, someone who can mentor others while rolling up their sleeves to solve complex quality challenges, and someone who thrives in the dynamic environment where innovation meets regulatory compliance.

Required Qualifications:

• Bachelor's Degree in Engineering and 4 Quality Engineering experience in a regulated environment OR

• Master's Degree and 2 years of Quality Engineering experience in a regulated environment

Knowledge and Skills:

• Good questioning and problem-solving skills

• Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.

• Plans effectively and team oriented.

• Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA

• Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability

• Demonstrated history of successfully interpreting regulations, and procedures

• Demonstrated skill in statistical analysis and applied statistical methodologies

• Knowledge and understanding of IEC 60601 standards

Preferred Requirements:

• Capital system experience (Electro-mechanical)

• ASQ Certification

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

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.