Engineer – Combination Product Development, Prefilled Syringe (PFS) Platform
Amgen•Thousand Oaks, CA
•$88,281 - $119,439
About The Position
The Combination Product Development Engineer contributes to the development, verification, and transfer of prefilled syringe (PFS) platform technologies used in combination products. The role plans and performs engineering activities, evaluates data, prepares technical documentation, and coordinates with cross-functional partners. Depending on project assignment, the engineer may lead technical teams or workstreams supporting product development, platform development, and life-cycle management. The position supports reusable platform approaches that help product teams apply established device and packaging knowledge while meeting user, product, quality, and regulatory needs.
Requirements
- 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.
Nice To Haves
- 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.
- 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.
Responsibilities
- Lead assigned cross-functional technical teams or workstreams for product development, platform development, and life-cycle management initiatives, aligning 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, including design inputs and 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 promptly raise schedule, quality, or technical risks.
- Support continuous improvement of platform methods, test practices, and reusable technical data packages.
Benefits
- Health and welfare plans for staff and eligible dependents
- Financial plans with opportunities to save toward retirement or other goals
- Work/life balance and career development opportunities
- Retirement and Savings Plan with generous company contributions
- Group medical, dental, and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
