Biocompatibility Engineer - Aditi Consulting : Job Details

Payrate: $57.50 - $57.50/hr. Responsibilities:

• Provide Biocompatibility assessment for Company's vast majority of products falling into the category of Medical Devices
• Define applicable Biocompatibility tests to evaluate product compliance to ISO10993 standard
• Assure product biocompatibility to comply with EUMDR regulations
• Work with outside laboratory on Biocompatibility test definitions and arrangements
• Write final Biocompatibility assessment reports.

Qualifications:

• BS or MS degree in Biology/Chemistry or equivalent is preferred
• Min 5-year experience working in Medical Device industry is a must
• Knowledge of ISO10993 is a must
• Experience working with test laboratories for Biocompatibility product assessment
• Experience working with product development engineering to identify appropriate representative of product families
• Excellent writing and communication skills

Desired Skills:

• Experience in the scope of Biocompatibility for products for EUMDR compliance
• Experience in chemical characterization of materials
• Knowledge of ISO 10993 series of standards
• Design Biocompatibility testing strategy to provide efficient delivery of test results for BSI submissions
• Provide Bio comp risk assessment report based on test results

• Experience with BSI submissions for Biocompatibility
• Experience working with Class III, class II and class I devices

Pay Transparency: The typical base pay for this role across the U.S. is: $57.50 - $57.50/hr.Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi's use of AI technology, including calls from an AI Voice Recruiter. #AditiConsulting # 25 - 21260