Sr Device Assembly Engineer

Senior Device Assembly Engineer

The Senior Device Engineer is responsible for providing technical leadership for the commercial Confi Pen 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 Confi Pen 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.

• Lead design change implementation and lifecycle management activities for commercial Confi Pen 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 monitoring systems, and process capability to ensure robust manufacturing performance and product quality.
• Analyze force-displacement 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…