BD (Becton, Dickinson and Company) Quality Engineer II in Tempe, Arizona
This position supports product leadership and risk management of new product development.
This position is part of the R&D Product Engineering Team (MDR Project) whose responsibility is to support the EU MDR project timeline, including product remediation testing and label changes.
Leads development of risk assessments and test methods
Supports component qualifications, design validation / verification and process validation
Leads basic level 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
Quality engineering representation on Product Development Teams.
Participate and provide input to training on department/division procedures, and policies.
Participate in project planning, budgeting, scheduling and tracking.
Support internal and external supplier audits.
Develop and implement procedures to comply with corporate and industry standards.
Provide support to the regulatory department in writing technical submissions.
Provide positive example and actively promote compliance to division, corporate and industry standards.
Maintain a professional working relationship with internal and external customer and support staff.
Prepare and present project updates and technical discussions.
Support "Voice of the Customer" identification and translation into design inputs.
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…)
Working knowledge in some of the related business technologies.
Ability to develop solutions with moderate 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.
Working knowledge of code level review, software logic review, black box testing, and system validation.
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
Software application skills
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
Ability to lead creation of risk management files
Quality Engineering Certification (ASQ) or equivalent.
3-5 years (Master’s degree plus zero to three years) of engineering or Quality engineering experience within the medical device or equivalent industry. Supervisory experience and Master’s Degree preferred.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
BDPI is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.
Industry Standard/Category: Medical Device/ Quality
Career Level: entry level
Division Name: Bard Peripheral Vascular
Relocation Available?: No
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 1625 W. 3rd Street
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.