BD (Becton, Dickinson and Company) Quality Engineer II in Tempe, Arizona
Job Description Summary
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.
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.
Primary Work LocationUSA AZ - Tempe BPV Building 3
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