Sr Engineer PFS Platform and Lyo Kit

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll 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 youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Sr Engineer - PFS Platform and Lyo Kit

What you will do

Lets do this! Lets change the world!

In this vital role you will be part of a development and sustaining device engineering team that supports final product development ensuring the product meets all requirements for safety efficacy and functionality and product lifecycle management. They manage the creation and maintenance of design documentation in accordance with quality procedures. They 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.

This position is located in Thousand Oaks CA and requires up to 10% domestic and international travel.

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering and/or Operations experience OR

• Associates degree and 8 years of Engineering and/or Operations experience OR

• Bachelors degree and 4 years of Engineering and/or Operations experience OR

• Masters degree and 2 years of Engineering and/or Operations experience OR

• Doctorate degree

Preferred Qualifications:

• Bachelors degree in engineering or other science-related field with 7 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 21CFR820

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

• EU Medical Device Regulation 2017/745

• Excellent communication and technical writing skills

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 well 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 including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

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.

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.

Salary Range