Job ID R-403514 Date posted 08/24/2021

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
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Responsibilities

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.

The BDPI Drug Coatings team is focused on the advancement and continuous success of drug coated balloons, one of BD’s prized peripheral intervention products, and future combination products and technologies.  Our culture is a natural home for driven, strategic, and proactive people who want to trailblaze and innovate for patients.

Position Summary:

Primary focus of this position is to collaborate, assist and lead R&D engineering medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; building units for engineering; performing tests, and collecting and analyzing data.

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

  • Product builds: Assist, coordinate, track and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales. Sets up and operates manufacturing equipment.

  • Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development. Assists in conceptual input to the design of fixtures, tooling and equipment, as well as assists with recommendation, specification and procurement of capital equipment.

  • Documentation: Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and formal test protocols and reports which comply with GMP and Quality requirements.

  • Test Method Development: Review test methods during test method development and assists with test method validations.

  • Testing: Ability to perform tests by following instructions from development engineers; collect data and record test results; analyzing test data, organizing, and presenting to peers and management when it is necessary in a reportable format. Assists in the execution of test protocols and procedures. Sets up test equipment for testing to protocols.

  • Coordinates and manages testing of released protocols. Training: Provides process/test method training to manufacturing and QA personnel.

  • Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule.  Ensure equipment is operating properly. Obtaining quotes for testing and calibration.

  • Materials/Inventory: generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking including monitoring material and test inventory, shipping materials/receiving materials including to/from sterilization, ship testing and conditioning for R&D products, preparing commercial invoices and liaising with internal Customs specialists.

  • Supervisory/mentoring/coaching: peer-peer coaching other technicians on R&D based tasks and responsibilities. Oversee activities of junior technicians in conjunction with their Engineering supervisor.

  • Fiscal: reviews inventory reports, the transfer of R&D items to financial logs and relays information to R&D engineers/Project Leaders/R&D Managers for discussion with Finance.

Other Responsibilities may include, however are not limited to:

  • Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.

  • Assist in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:

  • Minimum of a Highschool Diploma/GED.  Associates of Science degree in science, math or engineering preferred.

  • Experience: Minimum 5-8 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 4 years related experience preferably in medical device or other regulated FDA/QSR and ISO environment. Ability to work without supervision.

  • Experience working in a laboratory and a controlled environment (cleanroom) with knowledge of GMP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for test or pilot processes, is a plus.

  • Experience in process validation (IQ, OQ and PQ); ability to assist in executing validation.

  • Proficiency in computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.

  • Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis. Exposure to statistical analysis and experimental design helpful.

  • Ability to design (fixture, equipment, and testing). Has general technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. Solidworks).

  • Interpret and understand geometric tolerances.

  • Experience of electronic tools and equipment (soldering, multi-meter, oscilloscope and analyzer, etc.) is preferred.

Preferred Qualifications:

  • Associates degree or higher in science, math or engineering preferred.

Education and/or Experience:

  • Minimum of a Highschool Diploma/GED.  Associates of Science degree in science, math or engineering preferred.

  • Experience: Minimum 5-8 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with 4 years related experience 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

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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

BENEFITS

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