Engineer

r 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

What you will do

Let's do this. Let's change the world. In this vital role you will join our Device Engineering group to support change control, engineering robustness, and device development. In support of Amgen's mission to serve patients, the Device Engineering group at Amgen is a diverse team working to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience.

The role will be responsible for driving and coordinating complex, cross-functional product development efforts, with clear ownership for managing interactions, dependencies, and interfaces to ensure program execution. The successful candidate will be a key member of the technical team that progresses towards the design, development, and transfer of drug delivery devices. The role ensures that the quality targets are satisfied, identifies technical risks and coordinates risk retirement activities on the program.

The position is based at our Amgen Massachusetts site with the possibility of a flexible working arrangement meeting business and private needs. You will be joining Amgen's device development team consisting of 50+ engineers.

Responsibilities:

The Engineer will be primarily responsible for end-to-end execution of Change Controls, with additional responsibilities supporting robustness engineering and design transfer activities. Specifically, the Engineer will:

• Lead end-to-end preparation and execution of Change Controls, including defining scope, rationale, and supporting documentation

• Partner with Change Owners, Document Owners, and SMEs to align timelines, impact assessments, and approvals

• Author and/or support redlining and finalization of controlled documents

• Ensure completeness, accuracy, and compliance of change records within the Quality Management System

• Support presentation of changes at Change Control Boards (CCBs)

• Support development and maintenance of the Design History File

• Support tasks within one or more of the Design for Robustness disciplines: Kinematic Design, Tolerance Design, Structural Strength Design, Material Design, DFA, DFM

• Collaborate across robustness disciplines to identify risks and mitigations, opportunities, and best trade-off solutions

• Collaborate closely with manufacturing, quality, and suppliers to improve product robustness and reduce variation-driven failures

• Apply systems-level thinking to anticipate how design decisions impact downstream manufacturability and performance

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:

• Master's degree
  OR
  Bachelor's degree and 2 years of Engineer experience
  OR

• Associate's degree and 6 years of Engineer experience
  OR

• High school diploma / GED and 8 years of Engineer experience

Preferred Qualifications:

• 2+ years of progressive experience as an engineer or scientist within a research & development, manufacturing, or engineering environment

• Experience with change control and configuration management in regulated environments

• Experience authoring technical documentation and working within a QMS

• Experience in medical device or combination product development under Design Controls

• Understanding of manufacturing processes (e.g., injection molding, assembly processes)

• Familiarity with technical drawings and specifications

• Working knowledge of relevant standards (21 CFR 820, ISO 13485, ISO 14971)

• Strong communication and cross-functional collaboration skills

• Ability to work with teams across functional areas, cultures, and time zones

• Fluent in English language

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 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.

Salary Range
88,281.00USD -119,439.00 USD