Sr. Engineer

Sr. Engineer### Sr. Engineer Apply:
Remote:
US
- Florida
- Tampa:
Full time:
Posted Today:
R-254500##
** 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.
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* 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
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* Preferred Qualifications:

*** Experience supporting FDA submissions, responding to regulatory deficiencies, addressing compliance concerns, or supporting audit readiness.
* Experience with process development,…