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Senior Device Engineer

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Amgen

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Location:
United States , Thousand Oaks

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Category:
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Contract Type:
Not provided

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Salary:

123098.00 - 149145.00 USD / Year
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Job Description:

The Senior Device Engineer serves as a technical leader in the design, development, and lifecycle management of drug delivery devices (e.g., prefilled syringes, vial kits) used in Amgen’s combination products. This role provides advanced engineering expertise, leads complex investigations, drives cross‑functional alignment, and influences decisions impacting Amgen’s strategic product portfolio.

Job Responsibility:

  • Serves as a technical leader in the design, development, and lifecycle management of drug delivery devices
  • Provides advanced engineering expertise, leads complex investigations, drives cross‑functional alignment, and influences decisions impacting Amgen’s strategic product portfolio
  • Accountable for ensuring that associated design history files for devices are robust, compliant, and strategically positioned for long-term sustainability
  • Seeks to enhance capabilities of the prefilled syringe and kit platform, evaluates and implements design changes as necessary, develops and strengthens technical standards, contributes to global product strategy and launches
  • Acts as a technical mentor to peers and junior engineers while representing the device engineering function across the broader Amgen network
  • Functions as a fully competent and highly independent subject-matter expert
  • Leads design and development efforts
  • Hosts and facilitates design reviews and assessments
  • 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
  • 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
  • Drives design improvements with development partners, contract manufacturers, and suppliers
  • 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

Requirements:

  • High school diploma / GED and 10 years of Engineering and/or Operations experience
  • Associate’s degree and 8 years of Engineering and/or Operations experience
  • Bachelor’s degree and 4 years of Engineering and/or Operations experience
  • Master’s degree and 2 years of Engineering and/or Operations experience
  • Doctorate degree
  • 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

Nice to have:

  • Degree in Mechanical, Biomedical, or related Engineering discipline
  • Experience with products with ophthalmic indications
  • Experience with lifecycle management of commercialized medical devices or combination products
What we offer:
  • 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
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
January 16, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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