Biomedical Engineer II Job at Planet Group, Minnesota

T25MdUFSYkVxZjJCamtuNVljcm0xclloWmc9PQ==
  • Planet Group
  • Minnesota

Job Description

Additional position details from the manager:
  1. Can you please confirm your top 3 skills sets required?  Experience in a regulated industry. Knowledge of international and domestic regulations associated with biocompatibility.  Experience with assessing biocompatibility risk per ISO 10993 standards.
  2. Can you please confirm the 3 main responsibilities/day to day activities required for this role?Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements. Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective.  Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.
  3. What is your target years of experience? 5+ years
The individual in this position is responsible for evaluating the safety and compatibility of medical devices with biological systems.  The 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.
TECHNICAL SKILLS
Must Have
  • 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)
Nice To Have
  • Demonstrated problem solving and critical thinking skills
  • Effective verbal and written communication skills
  • Technical understanding of the effect processing has on material properties and performance
  • The ability to work well under pressure

Job Tags

Contract work,

Similar Jobs

AESI

Imaging Consultant Job at AESI

Albin Engineering Services, Inc. ( is looking for a Consultant - Software Architect, Image Analysis & AI/ML for one of our premier clients. This is a 1 year consulting position that will be an as-needed basis. It will be approximately 10-20 hours for the first quarter... 

Kaiser

Medical Social Worker III LCSW - Part Time Job at Kaiser

Job Summary: The Medical Social Worker III provides assessments, coordination, and implementation/ evaluation of professional social services...  ...Care Department : Edgemont MOB - Social Services - 0806 Travel : Yes, 10 % of the Time Kaiser Permanente is an equal... 

Bronx County District Attorney Office

Assistant District Attorney Job at Bronx County District Attorney Office

Join to apply for the Assistant District Attorney role at Bronx County District Attorney Office3 weeks ago Be among the first 25 applicantsGet AI-...  ...admission to practice law in New York required;NY residency and U.S. citizenship required on first day;Minimum 7+ years in... 

ACT Medical Group

Certified Home Care Aide (HCA)/CNA - In-Home Elderly Care Job at ACT Medical Group

 ...Now Hiring: Certified Home Care Aides (HCA) or CNAs Seeking HCA Certification Los Angeles County, CA Full-Time, Part-Time, or Per...  ...Certified Home Care Aides (HCA) or Certified Nursing Assistants (CNA) to care for patients in their homes throughout Los Angeles... 

PPG Industries, Inc.

Research Chemist Job at PPG Industries, Inc.

 ...As a Research Chemist , you will join the Silica business unit in QEMETICA to support the Physical Testing Labs to lead new product...  ...and report to the Research Manager. QEMETICA offers excellent medical, dental, and vision benefits; match 401k and retirement benefits...