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Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Job Responsibility:
Serve 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
Provide advanced engineering expertise, leads complex investigations, drives cross‑functional alignment, and influences decisions impacting Amgen’s strategic product portfolio
Ensure that associated design history files for devices are robust, compliant, and strategically positioned for long-term sustainability
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
Act 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, 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
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
Nice to have:
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
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, or for field sales representatives, a sales-based incentive plan