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
The main responsibilities of the position are to provide strategic vision and tactical implementation of the quality engineering role in support of new product development. The position will represent the QA team as a spokesperson and leader within NPD. Surgery has a wide range of products and technologies, and the leader must be able to adapt their quality assurance skill set and apply it to a breadth of difficult technical issues. The position requires strategic vision in building the organization’s skill sets and capabilities, as well as adapting the QMS to meet the ever changing needs of the business. The leader must have the ability to influence internal and external relationships, including the quality engineering staff, functional peers, upper management and suppliers. The leader will work closely with R&D, Manufacturing, Marketing and Regulatory Affairs, to collaborate on complex issues and apply critical thinking to each unique situation.
Essential Duties and Position Responsibilities
Design Assurance: Manage and mentor the AQE staff in support of NPD activities:
Creation of design inputs.
Evaluation and approval of new product designs, specifications and product test procedures.
Evaluation of HF&U activities, including Formative and Summative studies.
Designing and executing statistical engineering experiments to compare design alternatives, compare proposed product with competitive products and evaluate performance.
Co-ordination of biocompatibility testing on all new materials.
Development of test methods and test method validations for the adequate evaluation of designs.
Development and execution of Design Verification plans.
Development and coordination of Risk Management activities, including DFMEA.
Development of accelerated and real time shelf life plans.
Development of supplier and component qualification plans in support of NPD projects.
Providing the smooth transition of new products to manufacturing through the continuous review of all quality systems, inspection data and product yields.
Quality Engineering: Manage and mentor the AQE staff in support of sustaining activities:
Developing process and product controls to assure the consistent manufacturing of products to established specifications.
Development of processes and equipment validation plans.
Support failure investigation process to identify root cause of product, process, and system non-conformances in order to drive continuous improvement as well as corrective and preventive actions.
Develop and improve quality systems to facilitate business and quality objectives and compliance review and resolution process to ensure the organization is alerted to issues in time to resolve potential adverse effects on the customer, company, or business.
Interface with the Sr. Director, Quality Assurance Operations.
Qualifications, Knowledge, and Skills Required:
Bachelor Degree in Engineering or Technical Science required; Master’s Degree strongly preferred.
Minimum of 3 years’ experience managing Sr. level AQEs and/or a Platform team in an Engineering environment.
Minimum of 8 years’ experience in a product development environment.
Minimum of 3 years’ experience in the medical device industry.
Formal course work in Statistical Quality Control.
Ability to apply broad technical, business, and compliance knowledge to improve business results.
Ability to effectively negotiate and influence upper management, other departments, and industry.
Conceptual and practical knowledge of applicable processes, systems and validation processes and systems.
Ability to adjust to and assimilate new technologies and innovations.
Effective communication skills.
Effective problem solving techniques
Demonstrated leadership skills.
Ability to travel up to 20%. Remote opportunity will be considered.
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, or any other protected status.
Primary Work LocationUSA IL - Vernon Hills
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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.