Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryPosition is directly responsible for providing ongoing support for infusion Manufacturing. This person facilitates design change projects and validation activities for sustaining production products. They will engage in discussions identifying, documenting and reporting quality issues and ensures that each issue is appropriately triaged for continual manufacturability.
Quality Engineering is a fast paced, dynamic environment requiring decision making at the strategic and tactical levels. The job requires a highly motivated self-starter with an ability to work with minimal supervision in a team environment.
This role will serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability.
You will facilitate teams in identifying, documenting, assessing, correcting and preventing quality issues using risk analysis and root cause analysis tools. You will be responsible for quality planning and establishing and maintaining metrics to improve quality system processes, process capability, reliability and quality of products.
- Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes
- Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
- Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
- Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable
- Work with Engineering and R&D to develop reliability testing plus modeling methods specific to products and systems for HALT, Shock and Vibration, MTBF and others as required
- Set Reliability goals for products and their subsystems in the field and measure against progress. Maintain a knowledge base of lessons learned to enable continuous improvement
- Manage and assess reliability risks that could adversely affect operations by providing analysis, diagnostics, and reporting. This will involve data analysis techniques to help companies meet accepted reliability standards.
- Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
- Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or related.
- Minimum 8+ years’ experience in quality assurance field in a regulated environment
- Minimum 6+ years’ experience in medical device industry
- Quality Certification preferred (e.g., CQE)
- Knowledge of medical device regulations (FDA 21CFR80.820, ISO13485, ISO14971)
- Results orientation with strong written and oral communications skills to lead cross-functional teams.
- Ability to effectively lead and influence cross functional teams.
- Strong problem identification and problem solving abilities.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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
Primary Work LocationUSA CA - San Diego TC Bldg C&D
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.