Job Description Summary

Primary focus of this position is to assist and lead R&D engineer medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; coordinating builds for engineering; developing and performing tests, and collecting, analyzing and presenting data and proposing recommendations to peers and management.

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:  

Primary focus of this position is to assist and lead R&D engineer medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; coordinating builds for engineering; developing and performing tests, and collecting, analyzing and presenting data and proposing recommendations to peers and management.

Responsibilities:

• Coordinates and tracks multiple product builds simultaneously for engineering evaluation, validation, clinical studies, and commercial sales. Assists in developing new processes for medical devices, provides input on tooling/equipment design, and supports procurement of capital equipment while ensuring compliance with GMP requirements.

• Initiates and implements comprehensive documentation including work instructions, SOPs, technical reports, and formal test protocols that comply with GMP and Quality requirements. Assists in design and process root cause analysis and supports non-conforming product investigations while ensuring regulatory compliance.

• Develops and validates new test methods, conducts tests in collaboration with engineers, collects and analyzes data, performs statistical analysis, and presents findings to peers and management. Sets up test equipment, coordinates protocol execution, and ensures proper equipment maintenance and calibration.

• Manages R&D inventory by generating purchase orders, coordinating with vendors, monitoring material and test inventory, handling shipping/receiving (including sterilization), preparing commercial invoices, and maintaining financial logs for R&D expenditures.

• Provides process/test method training to manufacturing and QA personnel, performs peer-to-peer coaching for junior technicians, and assists in supporting Manufacturing, Quality, Regulatory & R&D departments to ensure systems compliance with internal and external guidelines.

Required Qualifications:

• Minimum of a Highschool Diploma/GED. Experience: 9-12 years of industrial experience in R&D or process development,

• 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 required.

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

• Advanced proficiency in computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint) including Microsoft Project and Minitab for data analysis.

• Develops a working knowledge of, and assists in the completion of, Risk Assessments/FMEA, Design Verification/Validation Test Plans, and Process Validation Master Plans.

Preferred Qualifications:

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

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

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

• Interpret and understand geometric tolerances.

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