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.
Associate Director Systems Engineering
To advance Amgens mission to serve patients, we are hiring for the role of Associate Director Systems Engineer (ADSE) in Combination Product Operations. The Systems Engineering team provides expertise in the development, commercialization, and improvement of combination products to provide optimal patient experience in the administration of Amgens therapeutic products. The ADSE will report to our Director of Systems Engineering.
What you will do
Lets do this. Lets change the world! In this vital leadership role, you will manage a team of Systems Engineers to ensure the success of multi-functional drug delivery and combination product development efforts through their lifecycle from feasibility through commercial manufacture and lifecycle management. ADSE and team will work in collaboration with commercial, research, and process development leadership and colleagues to ensure that the developed product(s) meet the needs of users and meet performance per established requirements. Lead the creation and management of design inputs and outputs including user needs, system requirements, system architecture, and integration of subsystems through clinical entry, market-entry, and lifecycle management. Ensuring robust systems approach and practices, in addition to robust system architecture across the interactions, dependencies, and interfaces of subsystems.
Specific responsibilities include but are not limited to:
- Recruit, manage, and develop robust systems engineering expertise in staff.
- Lead development and manage staff to lead the development of robust combination products/drug-device combinations for global markets using the best Systems Engineering principles.
- Spearhead system definition in conformance to global regulatory guidance and best engineering methods including robust design inputs and outputs for clinical and market entry.
- Ensure quality through integration of requirements, risks, and implemented mitigations through downstream design outputs.
- Drive system verification and validation strategies across platform and brand-specific presentations.
- Own system performance & reliability targets and subsystem allocations.
- Provides authorship and expert technical leadership for regulatory filings.
- Responsible for mentoring, supervising, and directing the professional development of more junior engineers.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Associate Director System Engineering professional we seek is a collaborative leader with these qualifications.
Doctorate degree and 3 years of Engineering experience
Masters degree and 7 years of Engineering experience
Bachelors degree and 9 years of Engineering experience
Associates degree and 12 years of Engineering experience
High School diploma / GED and 14 years of Engineering experience
3 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.
Beyond that, the preferred qualifications are:
- Prior personnel management experience
- Masters Degree or PhD in Engineering (mechanical, systems, materials, electrical, chemical, or biomedical engineering).
- 10+ years of demonstrated success in medical device, drug delivery, or combination product / drug-device combination development for clinical entry and market lifecycle.
- 5+ years of demonstrated success leading development of system architecture and design for medical device, drug delivery, or combination products/drug device combinations through product lifecycle.
- Demonstrated product design and development success through product launches in major global regulatory regions.
- Successful experience managing multiple projects in a deadline driven environment.
- Demonstrated strength in the development of user needs, market and system requirements, system and process verification and validation strategies, DOE / SPC / Risk Management methods.
- Proficiency in driving CTQ hierarchical decomposition (flow-down) to subsystems and components.
- Strong technical communication, 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.
The annual base salary range for this opportunity in the U.S. is $146,427 to 179,950.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
If 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 cancers, 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.