Amgen · 19 hours ago
Senior Device Engineer
Thousand Oaks, CA
Full-time
Onsite
Mid, Senior Level
4+ years expAmgen is a biotech company dedicated to serving patients with serious illnesses. The Senior Device Engineer will lead the design, development, and lifecycle management of drug delivery devices, ensuring compliance and strategic positioning while mentoring junior engineers.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Functions as a fully competent and highly independent subject-matter expert, applying advanced engineering judgment to evaluate, adapt, and create methodologies that solve complex technical challenges
Leads design and development efforts, influencing technical direction and ensuring alignment with prefilled syringe and vial kit platform strategy as well as regulatory expectations
Hosts and facilitates design reviews and assessments, both during development as well as post-launch for commercialized devices
Serves as a technical reviewer and approver for design documentation, analyses, and verification/validation packages
Directs system-level root cause investigations with cross-functional stakeholders, ensuring robust technical justification and durable corrective actions
Uses statistical tools, modeling, and risk-based frameworks to diagnose issues and develop data-driven solutions
Oversees creation and maintenance of design specifications, technical standards, protocols, test methods, and comprehensive engineering reports
Leads design verification and validation workstreams, FMEA leadership, and statistical process control efforts where applicable
Ensures technical records meet global regulatory expectations and withstand inspection scrutiny
Acts as a key technical representative within networked project teams, exercising influence across functions such as Product Quality, Regulatory, Process Development, Supply Chain, and external partners
Drives design improvements with development partners, contract manufacturers, and suppliers by integrating feedback, capability assessments, and manufacturability strategies
Contributes to long-term technology roadmaps and platform expansion efforts
Leads design changes, post-launch investigations, product optimizations, and scale-up activities
Supports and defends regulatory submissions, inspections, and commitments at a senior level
Serves as a technical mentor and coach to other core and extended team members
Demonstrates advanced working proficiency in 21 CFR 820 Quality System Regulation, ISO 14971 Risk Management, and design control processes
Qualification
Required
High school diploma / GED and 10 years of Engineering and/or Operations experience OR
Associate's degree and 8 years of Engineering and/or Operations experience OR
Bachelor's degree and 4 years of Engineering and/or Operations experience OR
Master's degree and 2 years of Engineering and/or Operations experience OR
Doctorate degree
Demonstrates advanced working proficiency in 21 CFR 820 Quality System Regulation, ISO 14971 Risk Management, and design control processes
Preferred
Degree in Mechanical, Biomedical, or related Engineering discipline
Extensive experience in medical device/combination product development, commercialization, and regulated manufacturing environments
Experience with products with ophthalmic indications
Experience with lifecycle management of commercialized medical devices or combination products
Proven ability to lead complex, cross-functional engineering programs from concept through launch
Deep expertise in design controls, applied statistics, reliability engineering, and advanced problem-solving methodologies
Strong verbal and written communication skills with the ability to tailor messaging at multiple organizational levels
Excellent communication and technical writing skill
Benefits
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.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-16
Pharmaceutical Technology
2026-01-16
2026-01-16
Company data provided by crunchbase