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 Summary
You will combine Design Control expertise, creative problem-solving approaches and strong analytical skills to improve the lives of people with diabetes. I am looking for an experienced engineer (8+ years in medical device) who can mentor junior members of the team and work under consultative direction on major projects and initiatives.
As directed by the Associate Director, the Staff Quality Engineer I will be a member of the BD Medication Delivery Solutions (MDS) - Hypodermic platform and is accountable for product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
- Consistent application of technical principles, theories, concepts and quality sciences / tools
- Makes measureable improvements to BD processes and procedures
- Ensures that all design control and production / process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements
- Is a team member representing Quality on new product development and sustaining engineering projects
- Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
- Contributes to the completion of specific programs and projects
- Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
- Independently determines and develops approach to solution
- May provide guidance and work direction to other team members
- Designs and performs development working independently within defined parameters with minimal supervision required
- Support of the following, however are not limited to:
- Design History File support
- Design Validation
- Design Reviews
- Design Verification plans, protocols, and reports
- Design Output
- Design Input
- Assessment of Change Request (ACR) Responses
- Risk Management
- Process Validations
- Identification of CTQ's
- Unit Quality Independent Reviewer During Design Reviews
- Handling of deviations and non-conformances
- Test method validations
- Supplier qualification
- Software validations
- Post Market Surveillance
- Situation Analysis
- CAPA – Root cause investigation and implementation of corrective / preventive actions
- Proper Use of Statistics (Sampling Plans)
- Advise on Regulations
- Liaise with Manufacturing Plants
- Provide functional support to cross-functional teams
- Internal and external audits
- Bachelor’s Degree in a technical discipline required.
- A minimum of 8 years relevant experience or a combination of equivalent education and relevant experience
- Training in design of experiments and statistics. Class II / III medical device experience. Knowledge of six sigma methodology preferred. Knowledge of design control principles (preferred). Ability to support internal / external audits.
- Certified Quality Engineer and Certified Quality Auditor (preferred).
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 NJ - Franklin Lakes
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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.