Product Development Engineer
Description
This position is responsible for working with R&D Engineers/Scientists/Managers to perform laboratory 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
- Performs, organizes, plans and documents R&D activities leading to new or improved medical products and processes
- Designs, reviews, plans, conducts and documents laboratory 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.
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.
- Strong critical thinking skills and ability to review large quantities of data to make decisions.
- Demonstrates resourcefulness in problem solving.
- Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
- 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.
EDUCATION and/or EXPERIENCE
- Minimum of Associate degree required. Engineering or science area major preferred.
- Minimum of 2-4 years of related experience in medical device, pharmaceutical or other regulated industry.
OR
- High school diploma or equivalent
- Minimum of 3-5 years’ experience in medical device, pharmaceutical or other regulated industry.
- Knowledge or experience of performing basic laboratory activities, safety protocols, and equipment.