Advantage Technical · 19 hours ago
Manufacturing Engineer
Advantage Technical is seeking an experienced Manufacturing / Process Engineer IV to lead clinical build lines and drive critical process development activities that support product commercialization. In this hands-on engineering role, you will own key deliverables such as process characterization, validation documentation, and production readiness while collaborating with cross-functional partners.
Responsibilities
Lead clinical build line activities , supporting process development and commercialization efforts
Own and deliver process validation documentation and process characterization studies
Partner cross-functionally with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing to ensure project success
Drive innovative process improvements using data-driven and Six Sigma methodologies
Design, coordinate, and execute complex engineering tests and experiments
Analyze complex data sets, draw clear conclusions, and communicate findings to technical stakeholders
Prepare detailed technical reports, specifications, and process documentation
Evaluate new technologies, equipment, and process changes for feasibility and robustness
Manage Capital Equipment Request Authorizations (CERAs) from justification through implementation
Lead and influence cross-functional project teams toward production and quality goals
Train, mentor, and provide technical direction to operators, technicians, and engineers
Embed quality into all engineering activities
Ensure compliance with all applicable quality system and regulatory requirements
Qualification
Required
5+ years of relevant engineering experience in manufacturing or process development
Bachelor's degree in Engineering (Mechanical, Chemical, Biomedical, or related field)
Strong background in process development, validation, and production support
Proven ability to lead complex technical projects in a cross-functional environment
Candidates must be authorized to work in the U.S. now and in the future. Visa sponsorship is not available for this role
Preferred
Knowledge of electropolishing processes
Hands-on experience with Keyence and Sensofar measurement technologies
Company
Advantage Technical
Advantage Technical aligns people and companies to create opportunity.
Funding
Current Stage
Late StageCompany data provided by crunchbase