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 R&D Laboratory Systems program. The R&D Lab Technician is responsible for testing, analyzing data, drafting protocols/reports, and tracking work activities. These activities must comply with GLP, Client UCC quality system and government regulations.

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 test reports, test methods, data analyses and data summaries.
• Support with routine visual inspections and documentation of combination product retains
• 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

· Associate or Bachelor's degree in a science or engineering discipline from an accredited college or university.

• 1-2 years experience in a laboratory environment, including basic laboratory activities, safety protocols, and equipment (considered a plus).
• 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 templates. Ability to write simple reports, and business correspondence.

MATHEMATICAL SKILLS
Ability to perform basic mathematical calculations. Working knowledge of statistics is a plus.

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.

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, manufacturing environment (i.e., noise, minimal heat and some chemical fume exposure), laboratory, and office settings. Operate and maintain laboratory test equipment and measurement instruments.

Consistent with Client's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.