Remote Senior Biocompatibility Engineer

Amgen Inc. (IR); Tampa, Northern (FL, KY); Hybrid; USD 115,000 - 156,000; Full time

Job summary

Amgen is hiring a Sr. Engineer in Tampa, FL, with remote options within the U.S. This role develops and maintains biological evaluation plans and related documentation per ISO 10993, leading risk-based assessments and cross-functional collaboration.

The Sr. Engineer will own the PIA process framework, standardize workflows, and mentor teams while supporting regulatory inquiries, audits, and ongoing process improvements across regulatory, quality, manufacturing, and development partners.

Qualifications

• Doctorate or Master’s with 2 years of biocompatibility standards or risk engineering experience
• Bachelor’s with 4 years of biocompatibility standards or risk engineering experience
• Associate’s with 8 years biocompatibility standards or risk engineering experience
• High school diploma / GED with 10 years biocompatibility standards or risk engineering experience
• Experience supporting FDA submissions, regulatory deficiencies, audit readiness, or remediation is preferred

Responsibilities

• Develop and maintain biological evaluation plans, reports, rationales and documentation per ISO 10993
• Lead risk-based assessments of device platforms, materials, and changes
• Coordinate with regulatory, quality, manufacturing, development and cross-functional teams
• Own continuous improvement of PIA process framework, playbook and workflows
• Serve as SME, support regulatory inquiries and audit readiness

Skills

Biocompatibility standards

Risk engineering

Regulatory submissions support

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen is hiring a Sr. Engineer in Tampa, FL, with remote options within the U.S. This role develops and maintains biological evaluation plans and related documentation per ISO 10993, leading risk-based assessments and cross-functional collaboration.

The Sr. Engineer will own the PIA process framework, standardize workflows, and mentor teams while supporting regulatory inquiries, audits, and ongoing process improvements across regulatory, quality, manufacturing, and development partners.