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BD (Becton, Dickinson and Company) Staff Quality Engineer II in Franklin Lakes, New Jersey

Job Description SummaryReporting 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.

Job Description

Main Responsibilities:

  • 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

  • Evaluation of customer requirements to identify applicable quality standards

  • Release product during development activities

  • Realization of quality functional reviews

  • 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:

  • Manufacturing sites with appropriate technological, problem solving, and resources to prevent and or minimize adverse situations.

  • Can be part of internal or external quality audit team.

Main Functional Interactions:

Internal:

  • Functional core team members R&D, Software Engineer, Operations, Medical Affairs, Regulatory Affairs

  • Platform (ADDS) leaders

External

  • BDMPS customers, suppliers, and regulatory bodies

POSITION REQUIREMENTS

Education

  • BS degree in in Engineering, or other scientific discipline

Experience

  • Quality Engineering experience or 12+ years industry experience (Healthcare/ Pharmaceutical)

Special Skills

  • Thorough understanding of industry regulations/standards: ISO 13485, IEC 60601, QSR, GMP

  • Knowledge of design control principles.

  • Thorough understanding of statistical methods for Quality Assurance

  • Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.

  • Prior experience with electro-mechanical devices or device with software.

  • 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, andsupervisory/leadership capability.

  • Ability to handle multiple projects simultaneously in an unsupervised environment.

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***** Individuals can be considered on a remote basis anywhere in the United States for this position.

#LI-OPS

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

Additional LocationsUSA AZ - Tempe Headquarters, USA MD - Baltimore

Work ShiftUS BD 1st Shift 830am-5pm (United States of America)

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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