Senior Quality Engineer

BD (Becton, Dickinson and Company)•Tempe, AZ

36d•Onsite

About The Position

This position supports product leadership and risk management of new product development and sustaining activities. 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. This position supports product leadership and risk management of new product development and sustaining activities. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Requirements

BS in Engineering
Minimum of five years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
Knows how products are used and impact the user(s) so that risk can be managed effectively
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
Ability to lead creation of risk management files
Ability to develop solutions with business impact
Advanced statistical and risk assessment techniques
Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
Ability to make and present risk-based decisions
Strong interpersonal skills
Ability to analyze and optimize manufacturing and quality systems
Product, design & prototyping
Ability to create and provide training
Problem solving ability
Ability to create, review and coordinate test protocols and reports
Ability to generate engineering proposals
Oral and written presentation skills
Ability to Lead cross functional teams
Understanding of regulatory requirements including ISO 13485, ISO 14971

Nice To Haves

Quality Engineering Certification (ASQ) or equivalent

Responsibilities

Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
Leads development of risk assessments and test methods
Leads component qualifications, design validation / verification and process validation
Leads product investigations
Ability to make and present risked based decisions
Assess product changes against product design
Supports translation of design inputs into manufacturing control plans
Develop and implement procedures to comply with corporate and industry standards.
Coordinates and/or directs all aspects of product development activity related to a product line
Leads development of risk assessments and test methods
Quality engineering representation on Product Development Teams and Design Review Teams
Prepare and present project updates and technical discussions
Participate in project planning, budgeting, scheduling, and tracking
Support internal and external supplier audits
Provide support to the regulatory department in writing technical submissions
Complies with company procedures and policies, government regulations
Ability to travel for business, project, and issues approximately up to 25% of time.
Other duties and projects, as assigned