Sr. Manager

1 month ago

Baltimore County, United States BD Full time

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. 

Responsibilities:
Lead Software Engineering Process Group:

Manage and lead a small team of associates whose focus is improving software processes and in turn software quality, specifically related to the areas below.

Software Quality:

Lead the development and implementation of software quality process strategies, policies, and procedures in compliance with FDA regulations, ISO 13485, and other relevant standards.

Perform risk assessments and develop mitigation strategies to address software-related hazards and ensure patient safety.

Conduct thorough reviews and audits of software development processes and deliverables to identify and resolve quality issues.

Oversee the design, implementation, and execution of software verification and validation activities to ensure software meets specified requirements and standards.

CAPA (Corrective and Preventive Actions):

Manage the CAPA process for software-related issues, including investigation, root cause analysis, corrective action planning, and effectiveness monitoring.

Collaborate with cross-functional teams to address and resolve CAPA findings in a timely manner, ensuring continuous improvement of software quality and reliability.

Regulatory Compliance:

Provide expertise and guidance on FDA Part 820 Design Controls and other regulatory requirements applicable to medical device software development.

Ensure software development activities adhere to regulatory standards throughout the product lifecycle, including design, development, testing, and post-market surveillance.

Support regulatory submissions and audits by providing documentation and evidence of compliance with applicable regulations and standards.

Change Control:

Develop and maintain change control processes for software development, ensuring that changes are properly evaluated, documented, and implemented while maintaining regulatory compliance.

Monitor and track changes to software requirements, design, and code, assessing their impact on product quality, safety, and effectiveness.

Project Management:

Utilize project management skills to develop comprehensive R&D project plans for software development initiatives, including defining project scope, objectives, timelines, and resource requirements.

Monitor project progress, identify potential risks and issues, and implement corrective actions to ensure projects are completed on schedule and within budget.

Qualifications:

Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, or a related field; advanced degree preferred.

Minimum of 10-15 years of experience in software quality assurance and process management within a regulated industry, preferably medical devices.

Strong understanding of FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and other relevant quality standards.

Proficiency in risk management methodologies and tools, including FMEA (Failure Mode and Effects Analysis) and risk assessment.

Experience leading CAPA investigations and implementing effective corrective and preventive actions.

Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.

Proven ability to develop and manage project plans, prioritize tasks, and meet deadlines in a fast-paced environment.

Certification in quality management (e.g., ASQ Certified Quality Engineer) and project management (e.g., PMP) is a plus.

Proven experience working with SAFe methodology in large-scale agile environments, with a deep understanding of agile principles and practices.

Proficiency in MS Azure DevOps, including configuration, administration, and customization of tools to support agile development processes.

Strong analytical skills and experience in interpreting and analyzing software quality metrics and performance data to drive continuous improvement initiatives.

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.

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