Job Description Summary

This position is responsible for working with R&D, Stability, Quality, and other cross-functional teams to perform R&D development activities and laboratory testing to support the MDR product stability program. The R&D Test Engineer is responsible for testing, analyzing data, drafting protocols/reports, non-conformance resolution, as well as planning, organizing, scheduling, and tracking work activities. These activities must comply with GLP, BD UCC quality system and EU MDR regulations.

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. 

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

• Designs, reviews, plans, conducts, and documents laboratory testing/experiments for the verification of medical devices and processes.
• Prepares protocols, test reports, test methods, data analyses and data summaries.
• Performs, organizes, plans, and documents R&D development activities.
• Develops, organizes, plans, validates, and documents test methods that may be used for product development.
• Address any test non-conformances through execution of UCC DDN process. 
• Produces and maintains laboratory documentation which thoroughly, neatly, and accurately record all R&D activities.
• Performs tests and experiments in accordance with the requirements of Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Quality System Regulations (QSR).
• Sets up, safely operate, and maintain laboratory equipment and test instruments.

QUALIFICATIONS

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must be a self-starter and work with minimal supervision.
• Ability to organize the priority of work requirements and effectively work with team members to assign, communicate, and meet realistic completion dates.
• Strong organizational skills and ability to work in cross functional teams.
• Strong interpersonal skills to include oral and written communication skills.
• Ability to create, review and coordinate test protocols and reports.
• Strong critical thinking skills and ability to review large quantities of data to make decisions.
• Proficient in the use of a personal computer with intermediate level of keyboarding skills. Proficient in MS Word, Excel, and databases.

EDUCATION and/or EXPERIENCE

• Bachelor’s degree in Science or Engineering field from a major university is required.
• 1-2 years experience in a laboratory environment, including basic laboratory activities, safety protocols, and equipment.
• Knowledge in design control processes, quality systems and project management is a plus.

LANGUAGE SKILLS
Ability to read, analyze, and interpret general technical procedures or government regulations. Ability to write protocols, simple reports, and business correspondence.

MATHEMATICAL SKILLS
Ability to perform basic mathematical calculations. Working knowledge of statistics desired.

REASONING ABILITY
This position requires good judgment. Ability to solve practical problems. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. All product and process development activities within a team are to be carried out according to the applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources. In addition, should be able to analyze data and suggests additional courses of action.

PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. Specific vision abilities required by this job include close vision and color vision. Some lifting up to 25 lbs. may be required.

WORK ENVIRONMENT
Exposure to warehouse, manufact