Sr. 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

Sr. Engineer### Sr. EngineerApply: Remote: US - Florida - Tampa: Full time: Posted Today: R-254500## **Career Category**Engineering## ## **Job Description**## Join Amgen’s Mission of Serving PatientsAt 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 engineeringexperience OR Bachelor’s degree and 4 years of biocompatibility standards or risk engineeringexperience OR Associate’s degree and 8 years of biocompatibility standards or risk engineeringexperience OR High school diploma / GED and 10 years biocompatibility standards or risk engineeringexperience**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 usAs 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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:* 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.## Apply now and make a lasting impact with the Amgen team.**careers.amgen.com**In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.## Application deadlineAmgen 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.## SponsorshipSponsorship 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..**Salary Range**115,494.60USD -156,257.40 USD