Engineer, Device Development

The Engineer of Device Development combines hands-on technical execution with ownership of the integrated device development roadmap across Viking Therapeutics’ pipeline, including platform strategy, lifecycle planning, resource forecasts, and proposed budgets. Within Technical Operations, the Engineer partners with internal Chemistry, Manufacturing and Controls (CMC), Drug Product, Analytical Development, Quality, Regulatory Affairs, Clinical, and Supply Chain teams and serves as the day-to-day technical interface with external device suppliers, component vendors, test laboratories, contract manufacturing organizations (CMOs), and contract development and manufacturing organizations (CDMOs).

The role executes design control deliverables, risk management, design verification testing, test method development and validation, and engineering characterization for device constituent parts of parenteral combination products, such as prefilled syringes, autoinjectors, and pen injectors. This work applies first-principles engineering analysis to device performance and drug-device interactions. The Engineer contributes device content to the Design History File (DHF), CMC documentation, and regulatory submissions supporting Viking’s lead GLP-1/GIP dual agonist program (VK2735) and additional metabolic and endocrine disorder pipeline assets.

The main responsibilities of this role include:

• Serve as the day-to-day technical lead for assigned device and combination product work streams.

• Execute design control deliverables in accordance with 21 CFR Part 820 (QMSR) and ISO 13485, including user needs, design inputs and outputs, requirements traceability, design review materials, and Design History File (DHF) content.
• Author and maintain device and combination product risk management files in accordance with ISO 14971, including hazard analyses, design, process, and use FMEAs, and traceability of risk controls verification and validation evidence.
• Plan and execute design verification testing, and develop, validate, and transfer physical test methods for device functionality, such as break-loose and glide force, injection time, delivered volume, activation force, and needle extension, consistent with ISO 11608 and ISO 11040 as applicable.
• Apply first-principles engineering analysis and modeling (e.g., fluid dynamics, solid mechanics, finite element analysis) to characterize injection force and injection time, and evaluate sensitivity to formulation viscosity, primary container dimensions, siliconization, needle gauge, fill volume, and temperature.
• Develop statistically sound test strategies and test matrices (e.g., sample size justification, tolerance intervals) to establish design robustness, evaluate component and manufacturing variation, and support device specifications, acceptance criteria, and control strategies.
• Lead or support root cause investigations into device performance issues and out-of-trend results; review in-process and release data for trends; and support the disposition of device engineering changes, non-conformances, deviations, and CAPAs for assigned programs.
• Support human factors and usability engineering activities in accordance with applicable FDA human factors guidance, including use-related risk analysis, formative studies, support of summative (validation) studies, and instructions for use.
• Oversee external partners' technical and quality performance, including review of design, tooling, and process development and technical input to the selection and qualification of device suppliers, component vendors, test laboratories, CMOs, and CDMOs.
• Support design transfer, technology transfer, and scale-up of device assembly and combination product manufacturing, including engineering, clinical, and process performance qualification (PPQ) campaigns, and serve as Person-in-Plant during key manufacturing campaigns as needed.
• Partner with Analytical Development on primary container closure selection and drug-device compatibility, including container closure integrity (CCI), extractables and leachables, biocompatibility, and shipping and transit evaluations.
• Author and review device and combination product technical content for regulatory submissions (INDs, NDAs/BLAs, MAAs) consistent with 21 CFR Part 4 combination product cGMP requirements, and support responses to health authority questions in collaboration with Regulatory Affairs.
• Manage timelines, deliverables, and technical risks for…