高级工程师
Sr. Engineer
### **职业类别**
工程
### **职位描述**
### 加入安进为患者服务的使命
在安进，如果你觉得自己是更大事业的一部分，那确实如此。我们的共同使命——为患有严重疾病患者服务——推动我们所做的每一件事。
自1980年以来，我们在对抗世界上最严峻的疾病方面，帮助开创了生物技术领域。我们专注于四个治疗领域——肿瘤学、炎症、普通医学和罕见病，每年惠及数百万患者。安进正在推进广泛的药物管线，用于治疗癌症、心脏病、炎症性疾病、罕见病以及肥胖及其相关疾病。作为安进团队的一员，你将帮助对患者的生活产生持久影响，我们研究、制造并提供创新药物，帮助人们延长寿命，过上更幸福的生活。
我们获奖的文化是协作、创新且以科学为基础的。如果你热衷于挑战，并能把握其中的机会，你将在安进团队中茁壮成长。加入我们，改变患者的生命，同时改变你的职业生涯。
**高级工程师**
### **你将负责**
让我们一起行动，改变世界。在这个关键角色中，你将根据ISO 10993和适用的监管要求，开发和维护生物评估计划、报告、科学依据及相关文件。该职位将领导基于风险的设备平台、材料和变更评估；解读技术标准并识别合规差距；并与监管、质量、制造、开发、供应商和其他跨职能团队进行协调。
高级工程师还将负责持续改进PIA流程框架，包括集中化的操作手册、标准化的工作流程、模板、培训材料、治理、知识管理以及流程效率和自动化的改进机会。高级工程师将作为内部专业领域专家，支持技术决策、审计准备、监管咨询、问题解决和跨团队的指导。
高级工程师还将：
- 对设备平台和材料变更进行生物风险评估；解读生物相容性数据和测试结果；并评估历史文档和技术差距。
- 根据安进的内部标准，担任相关技术标准的技术评估负责人。
查看英文原文
### **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
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.
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 deadline
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
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.
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**Salary Range**
115,494.60USD -156,257.40 USD