Sr. Engineer

Amgen; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock-based long-term incentives

Paid time off

Flexible work models

Job summary

Amgen is seeking a Sr. Engineer to develop and maintain biological evaluation plans, risk assessments, and technical documentation in line with ISO 10993 and regulatory expectations.

You will lead cross-functional teams across regulatory, quality, manufacturing, and development, drive continuous improvement of the PIA process, and mentor colleagues while supporting audit readiness and regulatory inquiries.

Qualifications

• Doctorate degree or equivalent in biomed/engineering.
• Master’s degree plus 2 years of biocompatibility standards or risk engineering.
• Bachelor’s degree plus 4 years of biocompatibility standards or risk engineering.
• Associate’s degree plus 8 years of biocompatibility standards or risk engineering.
• High school diploma with 10 years biocompatibility standards or risk engineering.

Responsibilities

• Develop and maintain biological evaluation plans and reports per ISO 10993.
• Lead risk-based assessments of device platforms and materials.
• Coordinate with regulatory, quality, manufacturing, development and suppliers.
• Improve the PIA process framework with centralized playbook and workflows.
• Mentor teams and support audit readiness and regulatory inquiries.

Skills

Biocompatibility standards

Risk engineering

Regulatory submissions

Cross-functional leadership

Mentoring teams

Education

PhD in biomedical engineering or related field

Master’s degree in a related field

Bachelor’s degree in related field

Associate’s degree with 8 years experience

High school diploma with 10 years experience

Tools

Regulatory databases

Quality systems (QMS)

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.

• 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. 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
• A 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. Refer to the Work Location Type in the job posting to see if this applies.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.