About The Position

This position is responsible for working with R&D Engineers/Scientists/Managers to perform testing and development (R&D) duties, as well as planning, organizing, scheduling, and tracking work activities. These activities must comply with GLP and/or the client UCC quality system. Essential Duties and Responsibilities including the following. Other duties may be assigned. Performs, organizes, plans, and documents R&D activities leading to new or improved medical products and processes Designs, reviews, plans, conducts and documents experiments for the verification of new or improved products and processes Develops, organizes, plans, validates, and documents test methods that may be used for product development. Prepares protocols, test reports, test methods and data summaries for Engineers or Scientists 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/or Quality System Regulations (QSR). Sets up, safely operates, and maintains laboratory equipment and test instruments.

Requirements

  • Mechanical skills - physical testing experience
  • Working in a regulated environment
  • Self-starter and work with minimal supervision.
  • Strong critical thinking skills and ability to review large quantities of data to make decisions.
  • Resourcefulness in problem solving.
  • Detail oriented and ability to organize large amounts of work and data.
  • Proficient in the use of a personal computer with intermediate level of keyboarding skills.
  • Proficient in MS Word, Excel, and databases.
  • Plans effectively and team oriented.
  • Strong interpersonal skills to include oral and written communication.
  • Ability to read, analyze, and interpret general technical procedures or government regulations.
  • Ability to write protocols, simple reports, and business correspondence.
  • Ability to perform basic mathematical calculations.
  • 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.
  • Ability to analyze data and suggests additional courses of action.

Nice To Haves

  • Biomedical Engineering, Mechanical engineering background, , Industrial engineering
  • Working knowledge of statistics desired.

Responsibilities

  • Performs, organizes, plans, and documents R&D activities leading to new or improved medical products and processes
  • Designs, reviews, plans, conducts and documents experiments for the verification of new or improved products and processes
  • Develops, organizes, plans, validates, and documents test methods that may be used for product development.
  • Prepares protocols, test reports, test methods and data summaries for Engineers or Scientists
  • 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/or Quality System Regulations (QSR).
  • Sets up, safely operates, and maintains laboratory equipment and test instruments.
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