BD · 2 months ago
Senior Staff Software Quality Engineer
USA NC - Durham - Roche Drive
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a Senior Staff Software Quality Engineer to join their New Product Development Team. This role is responsible for supporting QA-related R&D activities, ensuring compliance with design controls and risk management principles, and leading quality initiatives throughout the product development lifecycle.
Health CareMedical DeviceTechnical Support
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 advanced quality engineering tools including statistical analysis, sampling methodologies, and root cause investigation techniques
Serve as a mentor and knowledge resource for developing quality professionals
Qualification
Required
Bachelor's degree in a relevant degree field such as engineering and 15 years' experience with emphasis on R&D development, Quality Engineering and Design Controls OR
Master's degree in a relevant degree field such as engineering and 10 years' experience with emphasis on R&D development, Quality Engineering and Design Controls
Ability to travel up to 10%
Preferred
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
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
Company data provided by crunchbase