Sr. Engineer

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

Benefits offered by this job

Stock-based incentives

Bonus program

Retirement plan

Medical, dental, vision

Life and disability insurance

Flexible spending accounts

Paid time off

Flexible work models

Job summary

Amgen Inc. in Jacksonville, FL seeks a Senior Engineer to develop and maintain biological evaluation plans and reports in line with ISO 10993, leading risk-based assessments of device platforms and changes.

You will coordinate with regulatory, quality, manufacturing, and development teams, mentor colleagues, support regulatory inquiries, and drive continuous improvement of the PIA framework through standardized workflows and governance.

Qualifications

• Doctorate or equivalent biocompatibility expertise required.
• Experience with FDA submissions and regulatory inquiries is preferred.
• Regulatory and cross-functional collaboration experience.

Responsibilities

• Develop and maintain biological evaluation plans and reports per ISO 10993.
• Lead risk-based assessments of device platforms and changes.
• Improve PIA process framework with templates, workflows, and training.
• Provide internal technical guidance, audits readiness, and regulatory support.

Skills

Biocompatibility knowledge

Regulatory interaction

Mentoring / cross-functional

Education

Doctorate degree

Master’s degree + 2 years biocompatibility experience

Bachelor’s degree + 4 years biocompatibility experience

Associate’s degree + 8 years biocompatibility experience

High school diploma / GED + 10 years biocompatibility experience

Job description

Career Category Engineering Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr. Engineer

What you will do

Let’s do this. Let’s change the world.

• In this vital role you will develop and maintain biological evaluation plans, reports, scientific rationales, and related documentation in accordance with ISO 10993 and applicable regulatory expectations.
• The role will lead risk‑based assessments of device platforms, materials, and changes; interpret technical standards and identify compliance gaps; and coordinate with regulatory, quality, manufacturing, development, supplier, and other cross‑functional teams.
• The Sr. Engineer will also own continuous improvement of the PIA process framework, including a centralized playbook, standardized workflows, templates, training materials, governance, knowledge management, and opportunities for process efficiency and automation.
• The Sr. Engineer will serve as an internal subject matter expert, supporting technical decisions, audit readiness, regulatory inquiries, issue resolution, and mentoring across teams.
• The Sr. Engineer will also: Perform biological risk assessments for device platforms and material changes; interpret biocompatibility data and test results; and evaluate legacy documentation and technical gaps.
• Serve as the Technical Assessment Lead for applicable technical standards in accordance with Amgen’s internal procedures, assessing impact to existing and emerging device platforms and developing risk‑based recommendations and mitigation strategies.
• Coordinate with regulatory, quality, manufacturing, engineering, development, suppliers, and other cross‑functional stakeholders to support technical assessments, compliance, audit readiness, and regulatory responses.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

Basic Qualifications

• Doctorate degree OR Master’s degree and 2 years of biocompatibility standards or risk engineering experience OR Bachelor’s degree and 4 years of biocompatibility standards or risk engineering experience OR Associate’s degree and 8 years of biocompatibility standards or risk engineering experience OR High school diploma / GED and 10 years biocompatibility standards or risk engineering experience

Preferred Qualifications

• Experience supporting FDA submissions, responding to regulatory deficiencies, addressing compliance concerns, or supporting audit readiness.
• Experience with process development, SOP creation, remediation, CAPA leadership, audit support, or integrated risk management processes.
• Experience collaborating with regulatory, quality, engineering, manufacturing, development, clinical, supplier, and external testing organizations.
• Experience establishing process governance, knowledge management, standardized workflows, training materials, or continuous improvement initiatives.
• Experience providing technical mentoring or serving as a subject matter expert in biocompatibility, biological safety, or related medical device disciplines.

What you can expect from us

From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models where possible.

Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Salary Range

Salary Range 115,494.60USD -156,257.40 USD

Sponsorship

Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen