Sr Device Assembly Engineer

About the role

The Senior Device Engineer plays a pivotal role in the commercial ConfiPen device assembly platforms, driving the technical leadership and innovation required to support the product lifecycle from design to global commercialization.

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.
• 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 laboratory activities supporting device assembly development, Design of Experiments (DOE), manufacturing investigations, and process optimization utilizing advanced assembly monitoring technologies.
• Lead technical investigations involving automated assembly equipment, force-displacement (force/travel) monitoring systems, and process capability to ensure robust manufacturing performance and product quality.
• 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.
• 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.

Qualifications

• 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.
• 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 in interpreting engineering drawings and using CAD software such as SolidWorks.
• Knowledge of ASTM, ISO, and applicable engineering standards.
• 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.