BD · 4 weeks ago
Staff Design Quality Engineer
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $206K/yr
5+ years expBD is one of the largest global medical technology companies in the world, dedicated to advancing health. The Staff Design Quality Engineer will ensure the quality and regulatory compliance of medical devices throughout their lifecycle, participating in design control activities, risk management, and fostering a culture of quality within engineering teams.
Health CareMedical DeviceTechnical Support
Responsibilities
Actively participate in product design and development activities, providing quality engineering support and guidance
Review and approve design inputs, design outputs, design verification, and design validation plans and reports
Ensure compliance with design control procedures, medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485), and company policies
Contribute to the development and maintenance of Design History Files (DHFs)
Lead and facilitate risk management activities, including the development and maintenance of risk management plans, hazard analyses, and FMEAs (Failure Mode and Effects Analyses)
Ensure appropriate risk mitigation strategies are implemented and verified
Support post-market surveillance activities by analyzing complaint data and identifying potential quality issues
Participate in root cause analysis and corrective and preventive action (CAPA) investigations related to design quality
Contribute to the effectiveness verification of CAPA actions
Support internal and external audits (e.g., FDA, ISO) by providing documentation and technical expertise related to design quality
Ensure ongoing compliance with all applicable quality system regulations and standards
Provide guidance and training to engineering teams on design control, risk management, and quality system requirements
Act as a mentor to junior quality engineers
Qualification
Required
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) required
5+ years of experience in Design Quality Engineering within the medical device industry
Demonstrated experience with medical device 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
Excellent analytical and problem-solving skills
Strong communication (written and verbal) and interpersonal skills, with the ability to effectively collaborate with cross-functional teams
Proficiency in statistical analysis and quality tools
Ability to interpret and apply complex regulatory requirements
Preferred
Master's degree preferred
ASQ certifications (e.g., CQE, CRE) preferred
Proficiency in relevant software tools (e.g., TeamCenter, Polarion, AzureDevOps, PLM systems)
Benefits
Rewards and recognition opportunities that promote a performance-based culture
Valuable, competitive package of compensation and benefits programs
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
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