Job Description Summary

The Sr. Quality Engineer is a key member of the New Product Development Team and is responsible for QA-related R&D activities from research through product launch. This position ensures that design controls and risk management principles are applied to new product development and sustaining engineering projects. This position also supports broader QMS activities (Audit, CAPA, Data Analysis, Installation & Servicing, Complaint Handling, etc.).

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.

Please note this role is in the Quality organization and has no direct responsibility for software testing (V&V).

Business & Product Overview

Pyxis® medication technologies combine proven technology with actionable intelligence to prevent medication errors, help free up caregiver time to focus on patient care, increase the predictability of medication availability, and reduce inefficiencies in the med use process. At almost every point in the med use process, safety and efficiency can be increased with the comprehensive capabilities of the Pyxis® medication management system. Learn more about Pyxis®: https://www.bd.com/en-us/products-and-solutions/products/product-brands/pyxis

Broader Duties for this role include:

• Responsible for being the core team quality representative for design control projects – new product development as well as sustaining efforts.

• Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.

• Provide clarification and guidance to teams on overall quality system with emphasis in design controls.

• Actively reviews design artifacts to ensure compliance with QMS and good documentation practices prior to final approval

• Work closely with program managers to ensure design deliverables are met and products can be commercially released in defined markets.

• Ensures effective verification and validation of design specifications and requirements.

• Reviews and ensures complete and comprehensive traceability of related design artifacts.

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

• Proactively engage partners to drive consensus and resolve issues in a timely fashion.

• Works collaboratively to drive root cause analysis of failures and structured problem solving for product development and manufacturing issues.

• Ensure product technical files and Design History Files are complete and auditable.

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

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 820, ISO 13485, ISO 14971 and IEC 62304 to support quality engineering activities

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

• Identify risks and proactively work with the program team to document risks and help to develop and ensure mitigation plans are in place

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

• Applies knowledge and skills to a wide range of situations

Desired Characteristics

• Software development experience within a regulated environment

• Strong background in software development methodologies

• Experience working in an iterative development environment like Scaled Agile Framework (SAFe) esp SAFe Certifications