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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
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