Sr Device Assembly Engineer

Amgen • New Albany, OH

1d • Hybrid

About The Position

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. Senior Device Assembly Engineer What you will do The Senior Device Engineer is responsible for providing technical leadership for the commercial ConfiPen device assembly platforms throughout the product lifecycle. This role leads engineering activities supporting device assembly equipment design, lifecycle management, manufacturing support, continuous improvement, and global commercialization of drug-device combination products. The position is responsible for the technical development and sustainment of ConfiPen devices and their final drug product assemblies, and packaging equipment, ensuring products and assembly processes continue to meet safety, quality, performance, reliability, and regulatory requirements. The engineer serves as a technical subject matter expert, partnering across Device Engineering, equipment system owners, Combination Products Organization, Manufacturing, Quality, Regulatory, Supply Chain, and external suppliers to support product improvements, troubleshooting, manufacturing investigations, design changes, and commercial launches. This position also leads engineering laboratory activities supporting device assembly development, Design of Experiments (DOE), manufacturing investigations, and process optimization utilizing advanced assembly monitoring technologies.

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 Haves

• 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)
• Demonstrated ability to provide technical leadership, influence cross-functional teams without direct authority, mentor junior engineers, and drive engineering decisions across complex development and commercial programs.
• Strong interpersonal, communication, and technical writing skills with the ability to coordinate engineering activities across multiple global sites.

Responsibilities

• 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.

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, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree