We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Quality Operations to ensure that products and processes comply with the relevant requirements of the Quality Management System. Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and internal systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Implement and sustain process improvement projects. Works with quality systems for re-engineering.

Key Responsibilities:
• Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Design related projects to ensure that products and processes comply with the relevant requirements of the Quality Management System.

• Review and approve Design control related documents such as Design Verification, Design Validations and technical summaries for product design changes following the design control system and using statistical tools.
• Performs and present Residual Risk assessment and subsequent activities as part of Post-Market Surveillance.
• Review and approve process improvements and process changes by means of the change control process to ensure product design intent is maintained (Design Control Engineering- DCE) as Quality representative.
• Collaborate and work in the development, implementation and sustaining of the project management program to guarantee projects proper implementation.
• Investigate moderately complex manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.
• Responsible for assuring validation / qualification of equipment, and process following appropriate procedures and meeting regulatory compliance requirements.
• Develop and support continuous improvement activities to enhance the Quality Systems, using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, SPC, Kaizen lean methods, DOE, etc.
• Analyzes data and interprets standard practices and procedures to establish recommendations for problem solving.
• Responsible for leading multifunctional teams to develop risk assessment activities; creating and maintaining Risk documents including Risk Management Worksheets, Design FMEA and Quality Control Plans for controlling product quality. Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process.
• Work with a multifunctional team to support investigations related to protocol failures based on engineering principles; analyze results and make recommendations.
• Other incidental duties assigned by Leadership

Education and Experience:

Bachelor's Degree in Industrial Engineering, Electronic Engineering, Mechanics, Mechatronics, Chemistry, Industrial Design or another related field. 2 Years of previous related experience Required.

Master's Degree or equivalent Internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Preferred.

Additional Skills:
• Good computer skills in usage of MS Office.
• Good documentation, communication and interpersonal relationship skills.
• Basic understanding of statistical techniques.
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Solid problem-solving, organizational, analytical and critical thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Knowledge of and adherence to Quality systems.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to build stable working relationships internally.
• Ability to comply with the standards, regulations, procedures and quality manuals applicable.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visithttps://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

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