Let’s get started
By clicking ‘Next’, I agree to the Terms of Service
and Privacy Policy, and consent to receive emails from Rise
Jobs / Job page
Assoc. Director of Engineering – Platform Technical Lead: Mechanical Autoinjectors image - Rise Careers
Job details

Assoc. Director of Engineering – Platform Technical Lead: Mechanical Autoinjectors

Career Category

Operations

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. 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.

Assoc. Director of Engineering – Platform Technical Lead: Mechanical Autoinjectors

What you will do

Let’s do this! Let’s change the world! We are currently seeking an Associate Director of Engineering – Platform Technical Lead for our Mechanical Autoinjector Platform. As part of the Combination Product Development (CPD) group, this role will support technical teams in the successful design, testing, - manufacturing and commercial sustainment of mechanical drug delivery devices for Amgen combination products. The Associate Director of Engineering will collaborate with global team members across systems engineering, process engineering, device development, packaging, primary containers, device quality, product delivery teams, and other groups.

In this role, the Associate Director will lead the testing, design transfer, post-market surveillance, and life cycle management of multiple autoinjector device commercialization efforts. This includes overseeing engineering, characterization, and GMP verification testing, while ensuring alignment with project goals and timelines. The position requires close collaboration with suppliers to enable capacity expansions and evaluate new design changes and improvements, and it demands strong technical background in mechanical engineering and functional leadership of technical teams focused on device design, testing, manufacturing, and regulatory compliance.

The role also requires ensuring compliance with regulatory requirements and quality standards for combination product technologies, while driving the continuous improvement of processes, methods, and tools used in the development and life cycle management of mechanical autoinjector devices. The Associate Director will oversee the creation of technical documentation, including test plans, protocols, reports, and regulatory submissions, and ensure alignment of project timelines, resource allocation, and risk management for successful device commercialization. They will also monitor and assess the lifecycle of mechanical autoinjector devices to ensure post-market performance and regulatory compliance.

Furthermore, the Associate Director will play a key role in supplier management, ensuring that quality and technical specifications are met at all stages of product development and supply. They will provide support to the manufacturing network by ensuring efficient production processes and resolving any technical issues that arise during manufacturing. In addition, they will support agency inspections and respond to Regulatory Technical Queries (RTQs), collaborating with regulatory and product teams to ensure timely and accurate responses to inspection findings or queries.

This role requires strong proficiency in technical team management, mechanical design, drug combination product technologies, and regulatory requirements. The successful candidate will be expected to collaborate with vendors and Amgen suppliers to facilitate the accurate planning and execution of design activities.

  • Provide leadership, oversight, and overall representation to Amgen’s Mechanical Autoinjector Combination Product platform

  • Proficiency in Fit to Platform Assessments, Product Technical Review, and Lifecycle management product strategies

  • Identify product issues/opportunities for ‘in scope’ device platforms and drive solutions for cross product implementation (within CPO, Product delivery and Supply Chain organizations)

  • Consider platform boundaries across operations, commercial, and regulatory labeling

  • Support appropriate prioritizing of programs, including product lifecycle management and compliance related activities

  • Direct management of professional engineering team responsible for technical assignments and life cycle management activities

  • Estimated travel is 10-20%

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 14 Engineering years of experience OR

  • Associate’s degree and 12 years of Engineering experience OR

  • Bachelor’s degree and 9 years of Engineering experience OR

  • Master’s degree and 7 years of Engineering experience OR

  • Doctorate degree and 3 years of Engineering experience

In addition to meeting at least one of the above requirements, you must have a minimum of 3 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

  • M.S. in Mechanical Engineering, Material Sciences or related areas experience with 6+ years of experience in the Medical Device industry and Pharmaceutical Industry

  • Combination product experience (Drug Product and/or Medical Devices)

  • Leadership experience in building and developing successful teams, delivering results, and shaping the future

  • Strong problem-solving skills with the ability to be a clear thinker, work through complex problems, and determine an end solution

  • Allocate resources, prioritize activities, and manage multiple partners to support leaders across the business including working with leaders across functions

  • Business acumen that lends itself to understanding the context and dynamics of pharmaceutical challenges that impact Platform alignment

  • Partners with business leaders to deliver high-quality outcomes using strategic decision making (DAI)

  • Thinks strategically about issues impacting an entire portfolio of therapeutics versus Platform adherence

  • Direct or In-direct staff management experience; including performance management, hiring and onboarding, and staff development

  • Excellent written and verbal communication skills together with demonstrated ability to work in a team environment

  • Experience with the fill finish manufacturing process (glass/elastomers/polymers), device assembly and packaging for medical (aseptic) applications

  • A passion to deliver excellent work product, develop others with an infective positive attitude

  • Ability to travel +/- 20% of time

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, including remote and hybrid work arrangements, where possible

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.

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

176,070.00 USD - 208,816.00 USD
Amgen Glassdoor Company Review
4.2 Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon Glassdoor star icon
Amgen DE&I Review
No rating Glassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star iconGlassdoor star icon
CEO of Amgen
Amgen CEO photo
Robert A. Bradway
Approve of CEO

Average salary estimate

$192443 / YEARLY (est.)
min
max
$176070K
$208816K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

Similar Jobs
Photo of the Rise User
Posted 10 days ago

Amgen is looking for a Principal Software Engineer, Anaplan Lead to spearhead design and deployment of Anaplan solutions that drive business performance in a fully remote role.

Photo of the Rise User
Amgen Hybrid US - Rhode Island - West Greenwich
Posted 10 days ago

Lead Amgen’s engineering teams in process and automation to drive innovation and ensure operational excellence in a mission-driven biotech leader.

Challenge Manufacturing Hybrid 789 Flatwood Industrial Drive, Spartanburg, SC 29303
Posted yesterday

Challenge Manufacturing invites skilled Manufacturing Engineers to enhance production efficiency and quality at their Spartanburg plant through innovative and cost-effective manufacturing solutions.

Aerospace engineering leader needed at GE Aerospace to drive repair development for aeroderivative engine operations with a focus on technical innovation and collaboration.

Photo of the Rise User
Posted 10 days ago

Experienced Manager needed to lead agile teams and manage data platform integrations at Cardinal Health's Commercial Technologies division.

Photo of the Rise User
Posted 5 days ago

Join Picogrid as a Senior Electrical Engineer to develop end-to-end electrical solutions for cutting-edge autonomous defense systems operating in challenging environments.

Photo of the Rise User
Social Impact Driven
Empathetic
Collaboration over Competition
Growth & Learning

Contribute to innovative autonomous vehicle safety by leading verification and validation testing of low and high voltage, telematics, and network systems at Waymo.

Photo of the Rise User
Posted 8 days ago

Lead and innovate in device and process technology as Director of Process Technology at Renesas Electronics, driving key semiconductor development initiatives.

Photo of the Rise User
Posted 10 days ago

Lead engineering teams as a Transmission Engineering Supervisor at AECOM, contributing to critical power delivery infrastructure projects.

Photo of the Rise User
Posted 14 days ago

Support the F/A-18 Super Hornet program as an onsite Product Review Engineer at Boeing, focusing on product and process improvements to extend aircraft service life.

Posted 13 days ago

Seeking a skilled Systems Engineer with networking expertise to support and innovate switch product development for defense applications at Pacific Defense.

Photo of the Rise User
Mission Driven
Social Impact Driven
Passion for Exploration
Reward & Recognition

Lead automation design projects at SpaceX to innovate and optimize high-volume manufacturing for Starlink’s consumer hardware.

Photo of the Rise User
Oshkosh Corporation Hybrid Hagerstown, Maryland, United States
Posted 9 days ago

Develop and maintain high-quality embedded software for vehicle control systems at JLG, a leader in construction industry solutions.

Photo of the Rise User

Lawrence Livermore National Laboratory invites experienced mechanical engineers to drive innovation in weapon system demonstrators through advanced analysis and simulation.

Posted 3 days ago

Niron Magnetics is seeking a Senior Motor Controls Engineer to design and develop motor controller hardware for groundbreaking Iron Nitride magnet-powered motors.

To serve patients. Amgen strives to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives. In everything we do, we aim to fulfill our mission to serve patients....

265 jobs
MATCH
VIEW MATCH
FUNDING
DEPARTMENTS
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
EMPLOYMENT TYPE
Full-time, hybrid
DATE POSTED
April 18, 2025

Subscribe to Rise newsletter

Risa star 🔮 Hi, I'm Risa! Your AI
Career Copilot
Want to see a list of jobs tailored to
you, just ask me below!
LATEST ACTIVITY
Photo of the Rise User
Someone from OH, Mansfield just viewed Customer Care Representative at Gas South
Photo of the Rise User
Someone from OH, Mansfield just viewed Customer Service Representative at TaxRise
Photo of the Rise User
Someone from OH, Cincinnati just viewed Life Science Content and Community Specialist at Quartzy