BD (Becton, Dickinson and Company) Quality Engineer I in Tempe, Arizona
Job Description Summary
This position supports product leadership and risk management of new product development and sustaining activities, including post-market surveillance activities and deliverables.
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance).
Collaborates in design control activities (design inputs, design outputs, design reviews, design verification, design validation, design transfer etc.).
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.
Quality engineering representation on Product Development 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.
Follows company procedures and policies, government regulations.
Other duties and projects, as assigned.
Required Qualifications for risk techniques and abilities include:
Knows how products are used and impacts the user(s) so that risk can be handled effectively.
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
Lead creation of risk management files.
Develop solutions with business impact.
Advanced statistical and risk assessment techniques
Working knowledge of test methods (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.
Strong interpersonal skills.
Ability to analyze and optimize manufacturing and quality systems.
Product, design & prototyping
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 multi-functional teams
Understanding of regulatory requirements including relevant standards (e.g., ISO 13485, ISO 14971).
Education and/or Experience:
BS in Engineering.
Minimum of two years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry.
Regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. They occasionally are required to reach with hands and arms and stoop, kneel or crouch.
Employees may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
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.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson, and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on 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, or any other protected status.
Primary Work Location
USA AZ - Tempe Headquarters
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.