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Job Information

BD (Becton, Dickinson and Company) Quality Engineer I in Vernon Hills, Illinois

Job Description Summary

Position Summary:

This position supports the activities required to support EU-MDR submission of products, including product gap assessments, planning, and remediation of gaps.

Job Description

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 ambitious global health issues.

Position Summary:

This position supports the activities required to support EU-MDR submission of products, including product gap assessments, planning, and remediation of gaps. This position can be fully on-site or hybrid (on-site and remote).

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

  • EU-MDR submissions: leads Quality activities surrounding EU-MDR submission of products.

  • Works with multi-functional teams to remediate gaps related to EU-MDR requirements and meets all timelines in line with division and business goals.

  • Project Management: Assists with creating strategic plans and budgets for EU-MDR. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.

  • Design to Manufacturing Transfer: supports product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.

  • Test Method Development & Validation: leads the development and validation of clinically relevant test methods that adequately challenge product design and processes.

  • Testing: Leads verification and validation activities for products and processes in support of EU-MDR requirements.

Other Responsibilities may include, however are not limited to:

  • Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.

  • Ability to make and present risked based decisions

  • Prepare and present project updates and technical discussions

  • 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

  • Assess product changes against product design

  • Supports translation of design inputs into manufacturing control plans

  • Prepare and present project updates and technical discussions

  • Provide support to the regulatory department in writing technical submissions

  • Align 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 optimally

  • 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

  • Solid understanding 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 multi-functional teams

  • Understanding of regulatory requirements including ISO 13485, ISO 14971

Required Education and/or Experience:

  • BS in Engineering

Preferred Qualifications:

  • Quality Engineering Certification (ASQ) or equivalent

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 connect 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 enjoy working 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.

This position may be eligible for a retention bonus at the end of the assignment.

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 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 IL - Vernon Hills

Additional Locations

Work Shift

NA (United States of America)

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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