Engineer II

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.

Engineer II

What you will do

Let's do this. Let's change the world. In this vital role you will be part of a development and sustaining device engineering team that supports final product development of Electromechanical Device Platforms. You will be responsible for ensuring the product meets all requirements for safety, efficacy, and functionality through product lifecycle management. You will manage the creation and maintenance of design documentation in accordance with quality procedures.

You will be part of multi-functional teams responsible for the development of drug-device combination products.

Responsibilities:

* Providing guidance on combination product and device design requirements and specifications

* Leading product test strategies and execution to demonstrate product safety, performance, and efficacy

* Manage combination product and device Design History Files

* Analyzing data to support design acceptance, performance capability, and failure analysis

* Creating and driving test protocols, methods, and reports

* Transferring of technical information to manufacturing sites and support manufacturing scale-up and launches

* Employ basic engineering skills and practices to gather user requirements and translate them into documentation

* Engaging suppliers and development partners regarding specifications and quality levels

* Provides authorship and expert technical leadership for regulatory filings

* Managing project scope, schedule, and budget

* Owns and support quality records, change records, and deviations

* Supports device design complaint investigations and tracking to ensure timely resolution and continuous improvement

* Collaborate with Process Development and external partners as a technical authority.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these qualifications.

Basic Qualifications:

* Master's degree

* Or

* Bachelor's degree and 2 years of Engineering and/or Operations experience

* Or

* Associate's degree and 6 years of Engineering and/or Operations experience

* Or

* High school diploma / GED and 8 of Engineering and/or Operations experience

Preferred Qualifications:

* Bachelor's degree in engineering or other science-related field with 5+ years of relevant work experience with demonstrated ability in operations/manufacturing environment

* Experience in medical device, pharmaceutical or a similar regulated industry

* Background in development and commercialization of medical devices, and knowledge of manufacturing processes

* Understanding of the following standards and regulations:

* Quality System Regulation - 21

CFR
820

* Quality Management System for medical device/component manufacturers - ISO 13485 Risk Management for Medical Devices - ISO 14971

* Excellent communication and technical writing skills

What you can expect of 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…