Biomedical Engineer II Job at Development Resource Group, Minnesota

SnVNOGk1Ulo2aFFWZUwxQzJiZDZqRlJYNVE9PQ==
  • Development Resource Group
  • Minnesota

Job Description

The Biomedical Engineer II is responsible for evaluating the safety and compatibility of medical devices with biological systems. This role involves planning and placing biocompatibility testing in accordance with ISO 10993 standards, regulatory guidelines, and risk assessment principles. This individual collaborates with cross-functional teams to ensure materials meet safety requirements. This individual analyzes data, prepares technical reports, and supports regulatory submissions. This position may also be involved in developing strategies for new products and addressing biocompatibility related issues during product development and post-market activities.

POSITION RESPONSIBILITIES:

Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements. Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues. Review and interpret laboratory test results; document findings in technical reports and regulatory submissions. Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective. Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance. Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays. POSITION REQUIREMENTS: Bachelor's degree in materials science, chemical engineering, biocompatibility or a related technical field. Advanced degrees will also be considered. Experience in a regulated industry. Knowledge of international and domestic regulations associated with biocompatibility. Knowledge of materials and interactions with the body and environment. Knowledge of Microsoft applications (Excel, Word, Outlook) Development Resource Group

Job Tags

Similar Jobs

B&M Global Services Manila

Labor & Employment Litigation Associate Job at B&M Global Services Manila

Overview Labor & Employment Litigation Associate at Baker & McKenzie LLP. This role is part of the firms domestic Labor & Employment Litigation practice in California. The position involves handling a diverse range of employment matters, including litigation of multi...

Geomagical Labs

Senior Web Engineering Tech Lead, IKEA Kreativ Job at Geomagical Labs

 ...Geomagical Labs develops 3D+AI home imagination experiences, used by tens of millions of consumers around the world, in partnership with IKEA. Our pioneering IKEA Kreativ app lets customers visually scan photorealistic models of their spaces using proprietary visual AI... 

Courier Connection

Box Truck Owner Operators Job at Courier Connection

 ...Courier Connection is now seeking experienced Box truck Owner Operator with their own 24ft/26ft box trucks for day loads. We do local, long distance and out of state. We have first come first serve on-demand loads. This is a 1099 position with weekly settlements.... 

BJC HealthCare

Operating Room Registered Nurse Job at BJC HealthCare

 ...Will Scrub and Circulate ~ Benefits Start 1st of Month After Hire ~ The BJC RN Career Ladder differentiates BJC as the place for nurses to work in the greater St. Louis area. ~ This is a tool to empower nurses to work at the top of their license and own their... 

Elevance Health

Investigator II Job at Elevance Health

 ...Investigator II Locations: Indianapolis, IN, Nashville, TN, Columbus, OH Hybrid: This role requires associates to be in-office...  ...with heavy emphasis in negotiation preferred. Health insurance, law enforcement experience preferred. For candidates...