Biocompatibility Test Engineer

We are seeking a Biocompatibility Test Engineer to join our growing team of dedicated technologists. This position will play a key role in supporting DEKA’s biocompatibility/sterility process across many projects, working with project cross-functional teams to provide biocompatibility, sterilization and other design safety deliverables in compliance with ISO 10993 and other regulatory guidelines.
How you will make an impact:

• As a Biocompatibility Test Engineer you will focus on the biocompatibility and toxicological evaluation of designs required for approvals and patient safety
• Working with team members and stakeholders, you will design and implement effective biocompatibility and sterilization testing strategies, plans and test procedures in accordance with FDA requirements, internal SOPs and standards
• Coordinate and facilitate testing related to sterile barrier integrity (packaging), sterilization validation, endotoxin, toxicology, drug stability and compatibility, particulate, and reprocessing validations
• Liaise with internal resources (engineering, regulatory, quality, clinical and manufacturing) and external resources, developing and coordinating test strategies with Contract Research Organizations (CROs) to ensure appropriate planning and execution of required testing
• Review test results to ensure design requirements are met
• Utilize problem solving skills and technical knowledge to troubleshoot testing anomalies
• Coordinate toxicological risk assessments with toxicologists for a variety of medical devices across the company
• Evaluate new designs and changes in design per organizational risk management practices to ensure effective, safe and compliant devices
• Manage multiple projects requiring biocompatibility and sterilization evaluations ensuring timely completion of required tasks to meet project schedules
• Maintain a knowledge of applicable external standards and regulatory requirements for the biological safety of medical devices and mentor the development of this knowledge in others
• Support Regulatory Affairs on preparing information related to FDA-related correspondences

To succeed in this role, you will need the following skills and experience:

• Bachelor’s degree in an engineering or scientific discipline such as Biomedical Engineering, Biology, Biochemistry, Chemistry, or Microbiology
• 1-3 years of experience in the medical device industry
• Attention to detail necessary to maintain the required documentation
• Excellent technical writing, verbal communication, and organizational skills
• Experience writing and reviewing test procedures and reports
• Good interpersonal skills and demonstrated success working in a collaborative environment
• Ability to work independently with minimal supervision
• Experience with using good laboratory practices (GLP)

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