BD (Becton, Dickinson and Company) Quality Engineer II in Tempe, Arizona
Job Description SummaryQE II to support needle in-source synergy project
Becton, Dickinson Interventional (BDI) 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 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare. BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer. 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, respect, and feel valued, acknowledged and rewarded. Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.
General Purpose Summary:
This position will support transfer activities for ongoing cost improvement project that leverage synergies identified during the integration of Bard into BD. Molding and metal manufacturing experience is a plus.
Essential Job Functions:
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…)
Supervisor/Management Responsibilities: N/A
Fiscal/Budgetary Responsibilities: N/A
Customer and Key Contacts: N/A
Basic Skills/Competencies Required:
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
Ability to translate Voice of the Customer to Design Requirements and then to Manufacturing control plans
Quality Engineering Certification (ASQ) or equivalent.
Working knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO
- B.S. in Engineer or Tech Science
3-5 years relevant experience in the medical field or closely related industry
Molding and metal manufacturing experience is desired
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.
Bard Peripheral Vascular 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.
Primary Work LocationUSA AZ - Tempe BPV Building 3
Additional LocationsDOM Santo Domingo - Las Americas
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