Company: Artech Information Systems
Job ID: 18-39187
Job Title: Materials Engineer
Job Location: Mounds View MN
Job Duration: 12 Months
- The individual in this position will develop and execute the biocompatibility and hazardous substances analysis of medical device products, supporting the regulatory submission.
- This person will work under general supervision, assembling current design documentation, providing gap assessments and strategies to remediate in accordance with international standards and European medical device regulation.
- Provide technical support to regulatory submissions in the area of biocompatibility and Hazardous Substances.
- Provide assessments of existing and new medical device product against current medical device regulations and international standards.
- Determine activities needed to remediate medical device product biocompatibility and hazardous substance data to current requirements.
- Develop procedures for other engineers to show compliance to hazardous substances regulations.
- Document compliance of product to internal procedures.
- Minimum of a Bachelor's degree in a technical field with 4-6 years of relevant work experience
- Knowledge of materials and interactions with the body and environment
- Knowledge of international and domestic regulations associated with biocompatibility and Hazardous Substances
- Experience in a regulated industry
- Knowledge of Microsoft applications (Excel, Word, Outlook)
Desired or Preferred Qualifications:
- Effective verbal and written communication skills
- Ability to work well in a team environment
- The ability to work well under pressure
- The ability to evaluate, prioritize and manage multiple activities
- The flexibility to adjust work objectives to ensure the overall goals are met
- Demonstrated problem solving and critical thinking skills
- Technical understanding of the effect processing has on material properties and performance
- Ability to correlate material properties with product performance and predict various failure modes
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.967.3596 | Fax: 973.998.2599
Email: Rajesh.Kumar1@artech.com | Website: www.artech.com