BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) R&D Engineer I in Tempe, Arizona

Job Description Summary

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 challenging global health issues.

This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy. This position will support EU-MDR efforts and is anticipated to last approximately through September 2023.

Primary focus of this position is to support EU-MDR submission of products, including ISO 80369 luer mold redesign work. Work may also include product gap assessments, planning and remediation of gaps within project timelines, as needed. Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device, assist/write technical documents and CCPs, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development, support other activities from R&D, Quality, Operations, and Regulatory Affairs

Essential / Key Job Responsibilities:

  • Support of EU-MDR submissions: coordinates and/or directs R&D activities surrounding EU-MDR ISO-80369 luer mold redesign project.

  • Product Remediation (as needed): assists in aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering.

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

  • Project Management: creates, tracks and meets project schedules and budgets.

  • Assesses priorities to ensure project and company priorities are met.

  • 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: proposes and facilitates product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.

  • Documentation: Support teams by reviewing product development plans and participate in design reviews, review and approve technical documents and reports.

  • Reviews, approves and coordinates execution of verification and validation protocols and reports.

  • Develops and implements department and division procedures/policy.

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

  • Testing: Plan, develop, execute and manage verification and validation activities for products and processes in support of EU-MDR requirements.

  • Maintains a professional working relationship with internal and external customers and support staff.

  • Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.

  • Provides technical support on components, material methods, systems and equipment.

  • Oversees testing outlined in protocols and test methods.

  • Understands and follows company procedures and regulatory requirements.

  • Plans and coordinates engineering test builds.

Other Responsibilities may include, however are not limited to:

  • Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

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

Required Qualifications:

  • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.

  • Experience: 0-2 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.

  • Demonstrated hands-on technical aptitude.

  • Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization.

  • Excellent oral and written communication skills.

  • Ability to work in cross functional teams.

Preferred Qualifications:

  • Ability to assist in executing validation is a plus.

  • Knowledge of ISO-80369 and luer molds is a plus.

  • Ability to create, review and coordinate test protocols and reports.

  • Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.

  • Ability to make and present engineering decisions.

  • Oral and written presentation skills.

  • Knowledge of cGMP and GLP is a plus.

Education and/or Experience:

  • Education: B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.

  • Experience: 0-2 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.

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. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.

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.

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 AZ - Tempe Headquarters

Additional Locations

Work Shift

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

DirectEmployers