Salt Lake City, United States of America
1 day ago
Quality Engineer II
Job Description Summary

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Position Summary:

This position supports product leadership and risk management of new product development and sustaining activities.

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)

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

Leads development of risk assessments and test methods

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

Complies with company procedures and policies, government regulations

Other duties and projects, as assigned

Required Qualifications:

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.)

Ability to lead creation of risk management files

Ability to develop solutions with 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

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

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 including ISO 13485, ISO 14971          

Preferred Qualifications:

Quality Engineering Certification (ASQ) or equivalent

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

Physical Demands:

While performing the duties of this job, the employee is 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. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

Work Environment:

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. 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

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. 

Required Skills

Optional Skills

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Primary Work LocationUSA UT - Salt Lake City

Additional Locations

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