Quality Engineer, Analytical Development and Quality Control

Job Description

Vaxess is developing a pipeline of next-generation therapeutics on our novel micro-array patch platform. With only five minutes of wear-time on the skin, the Vaxess’ patch combines room temperature stability with simplified application to dramatically alter the way that drugs are delivered. Vaxess is committed to enabling products that are not only more effective, but also more accessible to patients around the world.

The Role

The Research Associate/Quality Engineer will be responsible for performing mechanical testing of materials and components using instruments such as Mecmesin, Instron, or equivalent force-measurement systems. This role will support tensile, compression, shear, puncture, and force displacement characterization to ensure product performance, robustness, and compliance with internal quality standards. In addition, the individual will contribute to method development, qualification activities, and routine QC release testing to support clinical and commercial manufacturing programs. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Key Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Perform mechanical testing of materials, components, and finished MAP products using Mecmesin, Instron, or comparable systems, including tensile, compression, shear, puncture, and force displacement profiling.
• Develop, optimize, and maintain mechanical test methods to support product characterization, comparability studies, and design verification/validation activities.
• Execute routine QC mechanical release testing aligned with cGMP expectations and data integrity standards.
• Troubleshoot mechanical testing issues, support instrumentation maintenance, and ensure proper calibration and documentation
• Analyze mechanical test data, prepare technical reports, and document all activities in audit-ready laboratory records.
• Collaborate cross-functionally with QC, Analytical Development, Process Development, Manufacturing, and Regulatory teams to enable program success.
• Assist in broader QC testing efforts as needed, including support for analytical, functional, and stability assays.
• Independently author method SOPs, analytical protocols, technical reports, and contribute to regulatory submissions.
• Maintain rigorous laboratory documentation and complete, audit-ready analytical records.
• Collaborate effectively with QC, Manufacturing, Process Development, and Regulatory teams to enable program success across phases.
• Thrive in a fast-paced, cross-functional environment with excellent communication and organizational skills.

Qualifications\t\t

• Bachelor’s degree in Mechanical Engineering, Materials Science, Biomedical Engineering, or a related discipline; 1–3 years of relevant mechanical testing or QC experience, or a master’s degree with applicable laboratory experience.
• Hands-on experience with mechanical testing instruments such as Mecmesin, Instron, Texture Analyzer, or equivalent force-measurement systems.
• Demonstrated proficiency in tensile, compression, shear, puncture, and force–displacement mechanical characterization.
• Experience developing, optimizing, and/or qualifying mechanical test methods for materials, components, or finished products.
• Familiarity with GMP, GLP, or ISO 17025 laboratory environments and strong understanding of data integrity (ALCOA+).
• Ability to analyze mechanical test data, generate clear technical reports, and maintain accurate documentation.
• Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus.
• Strong organizational skills with the ability to manage multiple workflows and prioritize effectively in a fast-paced environment.
• Excellent verbal and written communication skills and comfort working within interdisciplinary teams.
• Commitment to collaborative work within interdisciplinary project teams.

At Vaxess, we’re bringing together exceptional talent to drive our product development forward. We value collaboration, curiosity, and a dynamic work environment. To apply, please submit your CV/resume to careers@vaxess.com.