- Bachelor of Science Degree in Organic Chemistry, Polymer Chemistry, or Material Science required
- A minimum of 3 years' industrial experience. Experience in the Medical Device space strongly preferred
- Experience with standard spectroscopic techniques, FTIR, Raman, NMR is required
- Experience with HPLC is advantageous
- Experience working in cross-functional team in a Regulated Medical Device Environment (ISO 13485)
- Familiar with Quality and Regulatory systems for medical devices, including Combination Drug Products
- Strong organic chemistry and analytical/problem-solving skills, with demonstrated ability to collect, summarize and report technical information
- Strong computer skills with competency in MS Office (Word, PowerPoint, Excel, Outlook), MiniTab Software (as needed) and Microsoft Project
- Proficient in application of various statistical techniques and analysis
- Ability to prevent potential nonconformities before they occur
- Detail-oriented, highly organized team player
- Excellent verbal, written and interpersonal communication skills
- Self-starter and motivated individual who works independently
- Heated and air-conditioned office environment
- Laboratory
- Cleanroom
- Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing areas.
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Organic Chemist - Eden Prairie, United States - Harland Medical Systems, Inc.
Description
Job Title: Organic Chemist
Status: Full Time – Non-Exempt
Reporting To: Senior Research Fellow
Position Purpose:
This position is responsible for formulation development, analysis, and testing of polymeric films. This position is responsible for the creation or modification of polymers, leading to new coatings for medical device manufacturing. Experience with polymer synthesis and modification, and familiarity with the Medical Device industry is highly desirable.
Success is based on achieving a high level of confidence in the composition and performance of the material leading to design control, in a reasonable time frame. This candidate is expected to effectively communicate and advocate appropriate procedures and pathways to enhance technical achievement, and to provide a level of validation based on substantiated conclusions, derived from standard/internal or contracted test procedures.
This position is required to apply sound theoretical principles to interpret complex issues and reach conclusions that address the business needs. The Organic Chemist must have a talent for creation, synthesis, solving chemical problems, and making relevant decisions that provide supporting data driving technical solutions.
Education, Qualifications and Experience:
Working Conditions and Health & Safety:
Harland Medical System's commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System's internal procedures, where deemed appropriate per assigned job functions.
Physical Demands:
The position is primarily in a laboratory environment and the employee will be required to stand for much of that time. The employee is frequently required to talk and hear; use hands to finger, handle or feel; and reach with hands and arms above shoulder height and below the waist. Using proper lifting techniques, the employee must be able to lift up to 40 lbs.
