BD (Becton, Dickinson and Company) Quality Engineer II in Salt Lake City, Utah
Job Description Summary
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.
Duties and Responsibilities:
Lead and support new product development execution of design control from concept through post-launch phases.
Lead execution of risk assessments and test methods.
Support component qualifications, design validation / verification and process validation.
Lead basic level product investigations.
Support design change activities through product lifecycle.
Supports translation of design inputs into manufacturing control plans.
Quality Engineering representation on Product Development Teams.
Support internal and external supplier audits.
Develop and implement procedures to align with corporate and industry standards.
Provide support to the regulatory department in writing technical submissions.
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 handled optimally.
Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc…)
Bachelor degree in STEM (Science, Technology, Engineering, Math), and four (4) year of engineering experience within the medical device or equivalent regulated industry OR,
Master’s degree in STEM and two (2) yearsof engineering experience within the medical device or equivalent regulated industry.
Solid understanding in some of the related business technologies.
Ability to develop solutions with moderate business impact.
Working knowledge of statistical and software.
Confirmed understanding of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies.
Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.
Product, design & prototyping.
Software application skills.
Problem solving ability
Ability to create, review and coordinate test protocols and reports.
Ability to Lead multi-functional teams.
Understanding of regulatory requirements.
Solid understanding of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO
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 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.
Primary Work Location
USA UT - Salt Lake City
NA (United States of America)