Job Description Summary

The Staff Quality Engineer I - Software is the emerging Subject Matter Expert that is accountable to participate on project teams and manage Quality function deliverables.

This position will work with new or transferred products to administer the design control and validation elements of the Quality System to ensure regulatory compliance and robust product/process design for new software products and maintenance of existing software products. 

The position is accountable for the applications of industry standard quality practices and tools to the Instrument Plant and it's suppliers. 

Job Description

Responsibilities:

• Project Team Leadership - Serve as the quality champion across multiple development teams, bringing your expertise to new product creation and manufacturing transfer initiatives
• Regulatory Compliance Mastery - Ensure all projects meet or exceed customer expectations while navigating complex regulatory frameworks including:
  • FDA 21CFR820 Quality System Regulation
  • 21CFR11 Electronic Records requirements
  • ISO 13485 Medical Device Quality Management
  • ISO 14971 Risk Management protocols
  • IEC 62304 Software Lifecycle standards
  • European directives IVDD 98/79/EEC and MDD 93/42/EEC
• Computer System Validation Leadership - Spearhead validation activities and compliance assessments, ensuring data integrity across all platforms
• Software Development Lifecycle Excellence - Drive comprehensive quality throughout the entire development process:
  • Strategic development planning
  • Rigorous design input/output management
  • Meticulous design history file documentation
  • Seamless design transfer processes
  • Proactive change and risk management
  • Thorough design reviews for both application and embedded software
• Documentation Authority - Review and approve critical product documentation, technical drawings, and verification/validation processes with expert precision
• Data-Driven Problem Solving - Apply sophisticated statistical tools to analyze performance data, identify root causes, and implement effective resolutions
• Quality Strategy Development - Create and maintain innovative strategies to enhance overall software quality, test coverage, and system performance metrics
• Quality Engineering Leadership - Provide both strategic vision and tactical guidance based on deep understanding of 21 CFR Part 820 and ISO Requirements. 
• Design Review Ownership - Lead and facilitate comprehensive design and functional review processes specifically for software products
• Cross-Functional Collaboration - Partner with Manufacturing and R&D teams to drive software product improvements and monitor measurable quality enhancements
• Compliance Assurance - Ensure all divisional and departmental policies, procedures, and practices maintain regulatory compliance
• New Product Development Representation - Be the voice of Quality on core development and technology transfer teams
• GPDS Team Contribution - Deliver assigned software development deliverables including requirements documentation, development planning, risk management, and verification/validation
• Continuous Improvement - Lead remediation efforts for software-related audit findings and Corrective and Preventive Actions (CAPAs)

Required Qualifications:

• Bachelor’s degree in Electrical, Mechanical, Software or Biomedical Engineering or other relevant technical area and 9 years of experience, where 6 of those years are progressive experience in software development or lifecycle management.

Or

• MS/MBA with 7 years of experience, where 5 of those years are progressive experience in software development or lifecycle management.

• Demonstrated expertise typically evidenced through certification in at least one of the following ASQ-CQA/CQE/CSQE, AAMI, AOAC, Six Sigma, RAPS or a Company certification such as Green Belt, Black Belt, IGQA auditor, etc.

Skills:

• Ability and skill to effectively manage multiple tasks and lead execution of change management plans

• Ability and skill to lead or manage the Quality function for design projects, reliability concepts for complex systems, validation planning and statistical sampling, six sigma root cause analysis tools and project management techniques

• Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience

• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations

• Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems

• Ability and skill to analyze using systematic analysis tools that include Six Sigma, root cause, failure analysis and risk assessment to gather critical information and diagnose

• Ability to drive for results and effectively work through conflicts in working teams by facilitating conflict resolution

• Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO).

Required Skills

Optional Skills

.

Primary Work Location

USA MD - Sparks - 7 Loveton Circle

Additional Locations

Work Shift

US BD 1st Shift 830am-5pm (United States of America)

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$113,400.00 - $186,900.00 USD Annual