Key Responsibilities
Lead assigned cross-functional technical teams or workstreams for product development, platform development, and life-cycle management initiatives; align contributors on scope, technical deliverables, decisions, and milestones.
Develop and maintain technical work plans, schedules, dependencies, risks, and action tracking; communicate status and escalate issues that could affect scope, quality, or milestones.
Contribute to PFS platform development and life-cycle management activities, including design inputs, design outputs, verification, characterization, aging, and design transfer.
Plan and execute engineering tests for devices, primary containers, and packaging using approved protocols, procedures, and sampling approaches; document results and escalate unexpected outcomes.
Draft and revise protocols, reports, requirements, risk assessments, technical rationales, and other design-control records in applicable document and laboratory systems.
Analyze test data and technical information, identify trends or gaps, and communicate conclusions, limitations, and recommended follow-up to the project team.
Coordinate assigned work with partners in human factors, risk management, primary container, packaging, device, process, quality, manufacturing, and regulatory functions.
Support design transfer and site implementation by helping define test strategies, readiness needs, acceptance criteria, and documentation handoffs.
Contribute to investigation of device or component issues by reviewing returned-product or test evidence, supporting root-cause activities, and documenting technical findings.
Apply established procedures and engineering judgment to manage assigned tasks, meet commitments, maintain traceability, and raise schedule, quality, or technical risks promptly.
Support continuous improvement of platform methods, test practices, and reusable technical data packages.
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 Engineering experience
OR
Associate’s degree and 6 years of Engineering experience
OR
High school diploma / GED and 8 years of Engineering experience
Preferred Qualifications
Experience with prefilled syringes, injection devices, combination products, medical devices, or pharmaceutical packaging.
Experience developing or executing test protocols and reports, including functional, dimensional, performance, aging, or packaging evaluations.
Familiarity with design controls, risk management, requirements traceability, design verification, and design transfer.
Experience using electronic document management, laboratory notebook, requirements, or project tracking systems.
Working knowledge of statistical sampling concepts and data analysis tools.
Demonstrated ability to communicate complex technical information clearly in writing and verbally to technical and nontechnical audiences, facilitate discussions, and build alignment.
Experience applying project management practices to cross-functional engineering initiatives, including defining scope, milestones, dependencies, risks, and status reporting.
Strong interpersonal skills, including collaboration, active listening, relationship building, constructive conflict resolution, and motivating contributors without direct authority.
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.
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.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of 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. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
- .
- Salary Range
- 88,281.00USD -119,439.00 USD
