Director, Medical and Scientific Affairs, ADDS platform and innovation

2 weeks ago

Franklin Lakes, United States BD (Becton, Dickinson and Company) Full time

Job Description Summary

Position Summary

Performs quality assurance activities to ensure compliance with applicable medical device regulatory requirements. Contributes to the completion of specific programs and projects usually under the direction of a project leader. Good understanding and frequent application of quality assurance principles, design control concepts, industry practices, and standards. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and limited outside customer contacts.

Educational Background

Bachelor's degree in mechanical engineering, biomedical engineering or related engineering discipline.

Professional Experience

0-5 years of relevant experience

Job Description

Knowledge and Skills

a. Knowledge

* Good working knowledge of medical device regulations and practices (ISO 13485, FDA QSR, etc.).
* Practical and demonstrated experience of Quality or Reliability engineering, risk analysis, product development and verification/validation testing in the medical device industry.
* Demonstrated hands-on experience with Design Control procedures.
* Experience in a Phase-Gate development process.
* Experience in directly applying statistical methods for quality improvement.
* Good knowledge and understanding of process development, total quality tools, and continual improvement approaches.

b. Skills

* Good technical writing skills.
* Familiarity with statistical methods and analysis and/or Minitab software.
* Team player with excellent interpersonal and communication skills.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

* Familiarity with Six Sigma methodology.
* Experience in high volume manufacturing and assembly processes, particularly those of plastic injection molded parts and assemblies.
* Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
* Strong critical thinking, analytical, and problem-solving skills.

Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift

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