Sign upLog in

Sr. Staff Quality Engineer - New Product Development

Becton Dickinson

Durham, NC

Apply
JOB DETAILS
SKILLS
Agile Programming Methodologies, Automation, Centralized Operations/Management, Channel Strategies, Continuous Improvement, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Analysis, Documentation, Engineering, Establish Priorities, File Management, Hardware Administration, Hardware Development, Hardware-Software Integration, Hazard Analysis, Healthcare, Hospital Systems, ISO (International Organization for Standardization), ISO 9001, Identify Issues, Industry Standards, International Electro-Technical Commission (IEC), Internet Security, Lean Six Sigma, Mail Services, Maintain Compliance, Manufacturing, Marketing, Medical Equipment, Medications, Mentoring, Pharmacy, Problem Solving Skills, Product Development, Product Documentation, Product Lifecycle, Product Support, Product/Service Launch, Project/Program Management, Quality Assurance, Quality Engineering, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Reporting Skills, Requirements Management, Research & Development (R&D), Retail, Risk Analysis, Risk Management, Root Cause Analysis, Software Design, Software Development, Software Testing, Statistical Sampling, Statistics, Support Documentation, Systems Analysis, Team Player, Technical/Engineering Design, Traceability, V&V Testing, Validation Plan, Validation Testing, Verification Plans, Willing to Travel
LOCATION
Durham, NC
POSTED
1 day ago
Job Description Summary

We have an immediate opening for a highly motivated, results-focused professional to join our team, and are growing our staff as a Senior Staff Quality Engineer. The Quality Engineer's primary responsibilities are to support new product development activities, maintain compliance to company procedures and external standards, manage design history files, review design artifacts, participate in risk analysis activities, collaborate on product development deliverable documentation, support failure investigations, identify system issues, summarize findings and prepare reports for key quality metrics.

Please note this role is in the Quality organization and has no direct responsibility for software testing (V&V).

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

The Senior Staff Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects. This position also supports broader QMS activities (Audit, CAPA, Data Analysis, Installation & Servicing, Complaint Handling, etc.).

Business & Product Overview

BD's Pharmacy Automation Central Fill solutions are designed to transform high-volume prescription fulfillment into a streamlined, error-reducing, and scalable operation. These centralized facilities serve networks of retail pharmacies, hospital systems, care facilities, and mail-order services, enabling efficient medication distribution from a single location.

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 advasophisticatedlity engineering tools including statistical analysis, sampling methodologies, and root cause investigation techniques
  • Serve as a mentor and knowledge resource for developing quality professionals

Differentiating Qualities

These specialized experiences will set you apart as a candidate:

  • 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

Qualifications:

  • 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%

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

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.

#BDCLO

Required Skills

Optional Skills

.

Primary Work Location

USA NC - Durham - Roche Drive

Additional Locations

Work Shift

About the Company

B

Becton Dickinson