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Amgen Logo Amgen · IT - Software Development

Sr Device Assembly Engineer

United States, New Albany 115494.60 - 156257.40 USD / Year · Job Posted July 13, 2026
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Job Responsibility

  • Lead design change implementation and lifecycle management activities for commercial ConfiPen devices
  • Implement final drug product requirements, engineering specifications, and technical solutions for drug-device combination products
  • Ensure compliance with Design Control requirements throughout the product lifecycle
  • Support development of engineering strategies that ensure products meet safety, efficacy, functionality, and regulatory requirements
  • Lead cross-functional engineering teams supporting product development and commercialization activities as it relates to device assembly
  • Serve as the technical subject matter expert for device design, assembly processes, testing, and lifecycle management
  • Provide technical leadership to the manufacturing site and external development partners
  • Mentor junior engineers and provide technical guidance across multiple engineering disciplines
  • Manage project scope, schedules, budgets, technical risks, and engineering deliverables
  • Lead engineering investigations and process development activities within a laboratory environment to evaluate device assembly processes, materials, components, and manufacturing equipment
  • Design, execute, and analyze Design of Experiments (DOE) to characterize assembly processes, optimize critical process parameters, and establish robust operating windows
  • Develop laboratory test methods, fixtures, and engineering studies to support product development, lifecycle management, manufacturing investigations, and continuous improvement initiatives
  • Lead technical investigations by defining experimental strategies, developing hypotheses, selecting appropriate statistical methodologies, and translating results into actionable engineering recommendations
  • Partner with Process Development, Manufacturing, Quality, and external equipment suppliers to transition laboratory learnings into commercial manufacturing processes
  • Lead device assembly product testing to demonstrate product safety, performance, reliability, and efficacy
  • Develop verification strategies and author engineering protocols, reports, and technical documentation
  • Create and execute verification protocols, test methods, and engineering studies
  • Analyze engineering data using statistical methods to support design acceptance, process capability, and product performance
  • Support design verification, design validation, and engineering characterization activities
  • Support technology transfer activities to AOH manufacturing lines
  • Provide engineering support during manufacturing scale-up and commercial product launches
  • Lead troubleshooting of automated assembly and testing equipment
  • Utilize manufacturing data and in-process monitoring systems to identify trends, investigate process deviations, and drive continuous improvement
  • Collaborate with manufacturing teams to improve equipment reliability, process capability, and operational efficiency
  • Lead technical investigations involving automated assembly equipment, force-displacement (force/travel) monitoring systems, and process capability to ensure robust manufacturing performance and product quality
  • Analyze force-displacement (force/travel) signatures and process monitoring data to understand assembly behavior, identify failure mechanisms, and optimize assembly parameters
  • Develop, optimize, and validate assembly process windows utilizing statistical methodologies and engineering experimentation
  • Support qualification and optimization of automated assembly processes, including force-controlled assembly, press-fit operations, and functional testing
  • Collaborate with equipment suppliers and manufacturing engineers to implement process improvements and corrective actions
  • Own engineering change records, deviations, CAPAs, and quality records
  • Lead root cause investigations involving quality events, manufacturing issues, and device failures
  • Support Failure Mode and Effects Analysis (DFMEA/PFMEA) and product risk management activities
  • Provide technical leadership and authorship for regulatory submissions and technical reports
  • Ensure compliance with applicable Design Controls, Quality Systems, and global medical device regulations
  • Collaborate with suppliers regarding component specifications, manufacturing capability, and quality requirements
  • Support supplier qualification and component investigations
  • Interface with Process Development and external partners as the technical subject matter expert

Requirements

  • Understanding of global Medical Device Design Control regulations (21 CFR 820.30) and associated Design Control processes
  • Strong understanding of Design Planning, Design Inputs, Design Reviews, Design Verification, Design Validation, Design Transfer, and Design History Files
  • Demonstrated experience designing, executing, and analyzing Design of Experiments (DOE) to support product development, process optimization, and root cause investigations
  • Experience developing laboratory-based engineering studies to evaluate device assembly processes, equipment, and component interactions
  • Experience supporting and troubleshooting automated mechanical assembly processes and manufacturing equipment
  • Experience interpreting and utilizing force-displacement (force/travel) signatures to evaluate assembly performance, detect abnormal conditions, and support engineering investigations
  • Knowledge of manufacturing process monitoring systems, process capability analysis, and statistical evaluation of assembly process performance
  • Strong understanding of statistical methods including DOE, regression analysis, capability analysis, Statistical Process Control (SPC), and measurement system evaluation
  • Experience leading root cause investigations utilizing structured problem-solving methodologies
  • Experience supporting Design Failure Mode and Effects Analysis (DFMEA) and product risk management activities
  • Proficiency in interpreting engineering drawings and using CAD software such as SolidWorks
  • Knowledge of ASTM, ISO, and applicable engineering standards
  • Demonstrated ability to lead cross-functional teams including Engineering, Manufacturing, Quality, Regulatory, Supply Chain, Marketing, and external suppliers
  • Strong project management, communication, technical writing, and organizational skills
  • Doctorate degree OR Master's degree and 2 years of Engineering and/or Operations experience OR Bachelor's degree and 4 years of Engineering and/or Operations experience OR Associate's degree and 8 years of Engineering and/or Operations experience OR High school diploma / GED and 8 years of Engineering and/or Operations experience

Nice to have

  • Bachelor's degree in mechanical engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline
  • 7+ years of engineering experience supporting medical devices, drug-device combination products, or other regulated products
  • 5+ years supporting manufacturing or commercial operations
  • 3+ years of experience in medical device, pharmaceutical, or combination product development
  • Experience supporting drug delivery systems such as, pen injectors, wearable injectors, syringes, or related delivery platforms
  • Experience supporting engineering laboratories with device assembly development, manufacturing investigations, and process optimization
  • Experience with force/displacement monitoring systems or equivalent in-process assembly monitoring technologies
  • Experience developing assembly process windows using laboratory experimentation and statistical methodologies
  • Experience with automated assembly equipment including servo-controlled presses, force-displacement monitoring systems, vision inspection, and functional testing equipment
  • Experience analyzing force-displacement data to establish process capability, investigate failures, and improve manufacturing robustness
  • Experience with Design for Manufacturability (DFM), Design for Assembly (DFA), tolerance analysis, and mechanical assemblies
  • Experience supporting IQ/OQ/PQ and manufacturing process validation
  • Proficiency with Minitab, JMP, or equivalent statistical software
  • Proficiency with SolidWorks, CAD, engineering drawings, and assemblies
  • Strong understanding of: 21 CFR Part 820 / Quality System Regulation, ISO 13485, ISO 14971, EU Medical Device Regulation (2017/745), Combination Product regulations (21 CFR Part 4)

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, including remote and hybrid work arrangements, where possible
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