Job Information
BD (Becton, Dickinson and Company) Staff Quality Engineer II in Franklin Lakes, New Jersey
Job Description Summary
Job Description
Reporting to the Senior Manager, Quality Engineering for the BDMPS Franklin Lakes design center, the Staff Quality Engineer II for the Wearable Injector platform primarily supports combination medical devices with complex electro-mechanical drug delivery systems. The associate is responsible for combining design control expertise, creative problem-solving approaches, and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.
The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will 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.
Main Responsibilities:
Evaluation of customer requirements to identify applicable quality standards
Release product during development activities
Realization of quality functional reviews
Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
Consistent application of technical principles, theories, concepts and quality sciences / tools
Assist in electro-mechanical hardware integration
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
Collaborate with software engineers to develop requirements and perform hardware/ software integration
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
Liaise with Manufacturing Plants
Provide functional support to cross-functional teams
Define product control strategy
Lead risk management activities
Ensure design control elements are satisfied
Ensure/ perform process validation activities
Develop/ perform supplier qualification plans have been defined and completed
Evaluate test methods used in project activities
Ensure implementation of PS global procedures and standards for QE engineering activities
Provide support to internal, regulatory body and customer audits and associated corrective actions.
Develop systems, processes, and procedures related to project quality activities.
Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share.
Customer facing teams by providing technical support from a quality perspective.
Ensuring the terms on the agreement are being met.
Support drafting customer quality agreements
Share risk mitigation strategies and control plans for the device with the customers as applicable.
Qualifications
Education & Experience:
Bachelor’s Degree in Engineering or other scientific discipline, with a minimum of 12 years relevant experience or a combination of equivalent education and experience.
Special Skills:
Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP, IEC 60601, EU MDR
Knowledge of design control principles.
Thorough understanding of statistical methods for Quality Assurance
Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
Knowledge and experience in manufacturing, project management and engineering.
Good written and oral communication skills
Excellent problem solving and analytical skills
Must possess excellent oral and written communication skills, and supervisory/leadership capability.
Ability to handle multiple projects simultaneously in an unsupervised environment.
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.
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Primary Work LocationUSA NJ - Franklin Lakes
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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.