Sr. Engineer

Role: Senior Biological Engineer specializing in biocompatibility and risk assessment for medical device platforms within Amgen’s biotech pipeline. Objectives include developing evaluation plans, reports, and scientific rationales aligned with ISO 10993 and regulatory standards. Responsibilities encompass leading biological risk assessments, interpreting biocompatibility data, identifying compliance gaps, and coordinating cross-functional teams (regulatory, quality, manufacturing, development, suppliers) to support technical assessments, audit readiness, and regulatory responses. The role involves continuous improvement of the biological evaluation process framework, including standardization, training, and automation initiatives. Qualifications: Doctorate or Master’s with 2+ years or Bachelor’s with 4+ years of experience in biocompatibility standards or risk engineering; alternatively, high school diploma with 10 years of relevant experience. Preferred skills include FDA submission support, process development, SOP creation, and technical mentoring in biological safety or medical device disciplines. The position requires collaboration with diverse stakeholders across regulatory, quality, and engineering functions to ensure compliance and technical excellence. Location: Likely hybrid, with no specified travel requirements. The role emphasizes leadership in biological evaluation, compliance, and process improvement within the context of medical devices and biopharma development.