What are the responsibilities and job description for the Engineer - Cambridge, MA position at VetJobs?
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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
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
Auto req ID
470976BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
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.
Salary Range
88,281.00USD -119,439.00 USD
City*
Cambridge
State*
Massachusetts
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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
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
Auto req ID
470976BR
Minimum Education Required
High School/GED
Job_Category
Engineering
Additional Qualifications/Responsibilities
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.
Salary Range
88,281.00USD -119,439.00 USD
City*
Cambridge
State*
Massachusetts
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
$75,000-$100,000
Salary : $75,000 - $100,000