Design Verification Consultant u2013 Combination ...

Job Description The Design Verification Consultant will be responsible for shaping and executing design verification approaches for drugu2011device and combination product development programs. This role supports testing readiness and execution across component, subassembly, and finished product levels, including activities tied to clinical and commercialization pathways. Working closely with crossu2011functional stakeholders and external testing partners, the consultant will provide technical leadership across verification planning, method development, and testing execution. The position also contributes to adjacent activities such as manufacturing process validation, stability programs, and final assembly readiness. Success in this role requires strong technical judgment, proactive problem solving, and the ability to influence and align diverse teams. Key Responsibilities Define and drive design verification strategies supporting drugu2011device and combination product development programs across clinical and commercial phases. Develop, author, and execute design verification plans, protocols, and reports demonstrating alignment between product requirements and verification outcomes. Establish and guide development, qualification, and validation of test methods in alignment with applicable standards and regulatory expectations. Lead verification execution across internal teams and external laboratories, ensuring timelines, quality, and technical rigor are maintained. Plan and manage accelerated and realu2011time aging studies, including bridging approaches at component, subassembly, and finished product levels. Support testing readiness for critical development and commercialization activities such as Stability studies. Drug, product filling validations, Final assembly process validations, Transportation and distribution testing. Partner with quality, engineering, manufacturing, and regulatory functions to establish incoming inspection and release testing strategies. Provide oversight and technical direction to thirdu2011party testing vendors and development partners. Identify risks and constraints early, propose mitigation strategies, and communicate progress, challenges, and technical decisions to stakeholders. Support clinical supply builds by ensuring verification activities align with testing and release requirements. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements 8+ years of combination product development experience focused on design verification (Auto-injector, ophthalmic, and DPI) Experience supporting or leading design verification for combination product programs, including development of verification strategies, plans, protocols, reports, and associated test method development Experience with design controls, risk management practices, material selection and molding processes, manufacturing process development and validation, secondary packaging qualification, and overall design validation Knowledge performance testing related to container closure integrity (CCI), dose accuracy, and functional performance Knowledge of industry standards related to ISO 11608, ISO 11040, and ISO 80369 Experience in SolidWorks Advanced Degree in a related field

Created: 2026-02-19