Career CategoryEngineering
Job DescriptionSr. EngineerWhat you will doLet'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 youWe 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 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.comIn 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.
