Job Description Summary

Job Description

We are the makers of possible 

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. 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

The Staff Quality Engineer is a key member of the Dispensing Service Quality Team and is responsible for developing and maintaining data streams that are used to measure post market quality signals. This position ensures that quality engineering principles are applied to data analysis and sustaining engineering projects.

This position is to add Data Analysis and process capability to the Dispensing Service Quality organization. This position will work with data streams to solidify data into actionable information.

What is expected of you for success in your role:

• Demonstrates strong knowledge of quality engineering policies, principles and best practices

• Understanding of regulatory and international standards requirements including 21 CFR 210, 211, ISO 13485, ISO 14971 to support work with little or no supervision

• Applies comprehensive knowledge of software quality concepts within the software development lifecycle

• Knowledge of programming languages used to analyze post market signal (Python and SQL)

• Produce and analyze KPIs that effectively measure product performance from production log data and complaint analysis

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)

• Applies knowledge and skills to a wide range of standard and non-standard situations

• Works independently with minimal guidance

• Usually determines own work priorities

• Acts as a resource for colleagues with less experience

Duties include:

Developing and maintaining tools in the various systems that the business uses to measure post market quality. These systems include:

• Microsoft SQL Server, SSIS, Azure or AWS and machine learning algorithms.

• Produce and maintain dashboards that translate technical analysis results to actionable information.

• Languages: SQL (expert) and Python (knowledge)

• Provide guidance to the business regarding potential projects to improve the Quality of Dispensing products.

• Improving compliance through complaint and service signal analysis

• Create analytical engineered models from various input sources.

• Engage in cloud infrastructure decisions to ensure the needs of the business are met.

• Work closely with internal teams to ensure project timelines are met.

• Works together with Quality Engineers to improve signal integrity of post market quality systems.

• Active participant in the development of product requirements, product system hazard analysis and design reviews.

• Provide statistical support and expertise and analytical problem solving for product development and manufacturing

• Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams.

Qualifications:

• Bachelor’s degree in a relevant degree field (engineering) and minimum 8 years’ experience with emphasis on software development and data analysis.

• Experience with Software development experience within a regulated environment.

• Experience with SQL and Python programming languages is preferred - SQL is mandatory.

• Experience with SQL Server, and cloud solutions (Azure/AWS).

• Experience creating and maintaining dashboards in Tableau, Power BI and/or Quicksight.

• Ability to groom projects end to end to ensure a pragmatic approach towa