Vaxess Technologies · 3 weeks ago
Quality Engineer, Analytical Development and Quality Control
Woburn, MA
Full-time
Onsite
Entry, Mid Level
$60K/yr - $75K/yr
1+ years expVaxess Technologies is developing innovative therapeutics using a novel micro-array patch platform. The Quality Engineer will be responsible for performing mechanical testing and supporting quality control processes to ensure product performance and compliance with internal standards.
BiotechnologyHealth CareMedical
Responsibilities
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
Qualification
Required
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
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
Preferred
Experience supporting QC release testing, method qualification, method transfer, or equipment qualification is a plus
Company
Vaxess Technologies
Vaxess Technologies engages in developing biomedical innovations with a focus on improving access to vaccines.
11-50 employees
H1B Sponsorship
Vaxess Technologies has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (3)
Funding
Current Stage
Growth StageTotal Funding
$95.87MKey Investors
RA Capital ManagementNational Science FoundationThe Engine
2025-04-09Series Unknown· $9M
2024-05-22Series Unknown· $12M
2023-09-13Series Unknown· $9M
Leadership Team
K
Kathryn Kosuda
Co-founder, VP of Research & Development
Livio Valenti
Co-Founder, Senior VP of Strategy, BD and Operations
Recent News
EIN Presswire
2025-06-25
vcnewsdaily.com
2025-04-26
Company data provided by crunchbase