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 is a limited term 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 and is anticipated to last approximately through 12/20/24.

This position works multi-functionally and leads R&D activities needed in the development and transfer to manufacturing of products, processes, test methods and equipment for medical device manufacturing.

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

• Design: Understand design requirements, conduct gap analysis to ensure adequacy of design outputs (translating intangible design inputs into tangible engineering specifications and drawings) and ensure adequacy of verification and validation testing as part of transfer into manufacturing (to challenge designs against design specifications, clinical use scenarios and international standards).

• Process Development: assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate. Supports new process equipment and tooling development, including specification development, vendor selection and negotiation.

• Documentation: write technical documents and reports to detail engineering analyses conducted. Support development or modification of raw material specifications and engineering drawings. Assist in preparing verification and validation protocols and reports.

• Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods. Training: train technicians on new test methods and verification and validation testing.

• Supervisory/mentoring/coaching: May lead or run technicians or engineering interns.

Other Responsibilities may include, however are not limited to:

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

• Assist in 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 field.  Mechanical Engineering degree preferred.

• Experience: 1-3 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; ability to assist in executing validation.

• Excellent oral and written communication skills.

• Ability to work in cross functional teams.

Preferred Qualifications:

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

• Knowledge of cGMP and GLP is a plus.

• Training in Six Sigma or Design for Six Sigma is a plus.

Education and/or Experience:

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

• Experience: 1-3 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 verbal