Job ID R-401125 Date posted 07/11/2021

Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.

  • Job Type:
    Full-Time
  • Job Level:
    Entry to Senior
  • Travel:
    Varies
  • Salary:
    Competitive
  • Glassdoor Reviews and Company Rating

Responsibilities

Job Description Summary

This position is responsible for the coordination of activities to support EU-MDR submission of products, including product gap assessments, planning and remediation of gaps and management of assigned departmental personnel.

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 May 31, 2024.

This hire will ideally sit at our Tempe, AZ, Salt Lake City, UT or Vernon Hills, IL site. We are open to a more remote role however in that case there would be 50-60% travel required to these locations.

Job Description

  • Support of EU-MDR submissions: Coordinates and/or directs all R&D activities surrounding EU-MDR submission of Oncology products.
  • Product Remediation: coordinates and/or directs all 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. Creates strategic plans and budgets for EU-MDR and assesses priorities and makes assignments to direct reports 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.
  • Training: train technicians and engineers on design and process development and provide input to training of division procedures and policies.
  • Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through Product Development/Improvement/Maintenance activities. Typically supervises/manages various members of a R&D department, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions.
  • Fiscal: Creates, controls, manages a project budget (expense and capital expenditure). Create and critique engineering cost analysis. Reviews and analyzes costs to identify and implement cost improvements.

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.   Exposure to Biomedical Engineering or Bioengineering is a plus.
  • Experience: 8-11 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 6-8 years or Ph.D. degree with 4-6 years, medical device or equivalent industry experience). A minimum of 4 years’ experience in a supervisory capacity.
  • Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required.
  • Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
  • Ability to create and execute project plans and lead cross functional teams.
  • Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operating management.
  • Strong ability to analyze and use technical data and resources. Proficient in statistical analysis and related software.

Preferred Qualifications:

  • Masters degree in relevant engineering discipline.
  • Project Management Professional (PMP) or Scrum Master (PSM1) qualified.
  • Training in Six Sigma or Design for Six Sigma.
  • Knowledge of cGMP and GLP is a plus.

Education and/or Experience:

  • B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.   Exposure to Biomedical Engineering or Bioengineering preferred.
  • Experience: 8-11 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 6-8 years or Ph.D. degree with 4-6 years, medical device or equivalent industry experience). A minimum of 4 years’ experience in a supervisory capacity.

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.

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.

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

USA IL - Vernon Hills, USA UT - Salt Lake City

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Advancing the world of health™

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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.


Zakiyyah Walker
Staff Engineer

Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.


Michael Carrano
Senior Program Manager

BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.


Justyna Zielinska
Project Manager

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