HOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.Senior Manager - Systems EngineeringLive
What you will do
Lets do this. Lets change the world.
To advance Amgens mission to serve patients, we are hiring for the role of Senior Manager, Systems Engineering (SMSE) in the Combination Product Operations organization. The Systems Engineering team guides in the identification, development, commercialization, and improvement of drug delivery technologies to provide optimal patient experience in the administration of Amgens therapeutic products. The Systems Engineering team works in collaboration with commercial and research colleagues on the identification of user needs from market insights and leads the creation and management of system requirements, development of system architecture, and integration of subsystems while ensuring robust system architecture across the interactions, dependencies, and interfaces of subsystems.
As a leader within the Systems Engineering team, the SMSE will collaborate with the Director of Systems Engineering, executive leadership, and stakeholder functions from across the business to recruit and develop personnel and to develop portfolio product(s) and business processes. As a leader in the organization, the SMSE is key to ensuring the success of product development efforts from feasibility through the market entry and commercial manufacturing lifecycle.
The successful candidate will have demonstrated strength and success in managing interactions with key collaborators and colleagues from across process development, operations, research and development, and global commercial organizations to ensure accurate capture of the voice of customer and business into user needs.Role Responsibilities:
Responsible for recruitment, mentoring, supervision, and directed professional development of more junior engineers
Lead and mentor leadership responsible for the development of robust drug delivery systems and integrated development efforts applying the best Systems Engineering principles in combination product development cycles, including:
- Lead formal and ad-hoc technical and design reviews for the integrated system
- Spearhead system definition in conformance to global regulatory guidance and best engineering methods, including User Needs and System Design Inputs
- Responsible for DHF development and clarity of structure across the platform, combination product, and vendor structures to ensure quality and visibility
- Owns integration of user needs, requirements, risks, and implemented mitigations through downstream design outputs.
- Drives system verification and validation strategies across the platform and brand-specific presentations.
- Owns system performance & reliability targets and subsystem allocations
- Provides authorship and expert technical leadership for regulatory filings
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
- Doctorate degree and 2 years of Engineering experience OR
- Masters degree and 6 years of Engineering experience OR
- Bachelors degree and 8 years of Engineering experience OR
- Associates degree and 10 years of Engineering experience OR
- High school diploma / GED and 12 years of Engineering experience AND
- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Prior personnel management experience
- Masters Degree or PhD in Engineering in mechanical, systems, materials, electrical, or biomedical engineering
- 10+ years of demonstrated success in medical device, drug delivery, or combination product development for clinical and commercial entry
- 5+ years of demonstrated success leading development of system architecture and design for medical devices, drug delivery, or combination products from concept through market entry
- Demonstrated product design and development success through product launch in major global regulatory regions
- Successful experience managing multiple projects in a deadline-driven environment
- Demonstrated strength in controlled development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods
- Proficiency driving CTQ hierarchical decomposition (flow-down) to subsystems and components
- Strong technical communications, both written and oral at different levels of the business
- INCOSE certification or formal Systems Engineering training/certification
- Strong understanding of injection molding, electronics fabrication, system assembly and manufacturing processes
- Working knowledge of aseptic fill finish and controlled manufacturing environments
- Demonstrated success in platform product development with global multi-generation technology plans
- Robust knowledge of Quality Management Policies and Systems, practical experience in configuration management and change control process/requirements CCB (change control board), CIT (change implementation team) concepts
- Proficient with Production Part Approval Process (PPAP) methodology, documenting requirements and providing traceability documentation for FDA Approval - DOORS, Requisite Pro, or other similar requirements management software
- Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
- Familiar with the following standards: US Good Manufacturing Practices (21 CFR Part 4, 21 CFR 210/211, 21 CFR 820); Needle-based Injection Systems (ISO 11608-1); Quality Management (ISO 13485); Risk Management (ISO 14971); EU Medical Device requirements (EU MDR 2021); Medical Electrical Equipment (EN 60601)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.com
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.
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 requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.