Scientist(Extractables & Leachables (E&L) Scientist)

Intellectt Inc; Minnesota; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading medical equipment manufacturer seeks an Analytical Scientist in Minnesota. The successful candidate will handle E&L testing, collaborate with various teams, and ensure compliance with ISO and FDA standards. This position requires strong lab skills, effective communication, and the ability to work independently in a dynamic environment.

Qualifications

• 1-5 years of laboratory experience, familiar with ISO10993 and FDA requirements.
• Experience in extractions and sample preparations is crucial.
• Ability to maintain equipment and conduct analyses independently.

Responsibilities

• Perform E&L testing and operate analytical equipment according to standards.
• Support method development and maintain laboratory supplies.
• Document analyses using Lab Vantage Electronic Notebook.

Skills

Lab experience

Collaboration

Communication

Education

Bachelor’s degree in Chemistry, Biology, Material Science

Job description

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• Perform E&L testing including device extractions, non-volatile residue, FTIR, and ICP/MS analysis.
• The position is responsible for sample preparation, and operation of E&L analytical equipment.
• Hands-on on taking care of sample prep, extractions, routine maintenance of equipment, maintaining supplies, etc.
• Support GC/MS and LC/MS teams under senior chemist guidance.
• Operate and maintain analytical equipment per ISO10993, GDP, and GLP.
• Prepare samples and reagents, perform calibrations, and ensure supply stock is maintained.
• Document results using Lab Vantage Electronic Notebook system.
• Assist with method development, validation, and investigative analysis as needed.

What we are looking for:

• Someone that has previous hands-on lab experience-with extractions, supply prep, calibrations, maintenance of equipment, etc.
• Experience with ISO10993 part 18, GDP and GLP requirements in the medical device industry
• 1-5 years of experience within a full functioning lab and is familiar with various testing processes.
• Experience with FDA requirements/Medical Devices and testing/documentation for these.
• Bachelor’s, degree in Chemistry, Biology, Material Science, or related technical discipline
• Minimum of 2- 3 years of working within a full functioning lab.
• Needs associate to be able to jump in after being trained, so other associates can focus on current projects/testing.
• Candidate must have the ability to collaborate and work as a team player
• Ability to work and be effective with minimal supervision
• Strong verbal and written communication skills

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Manufacturing

• Industries

  Medical Equipment Manufacturing

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