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Job Title:

Senior Manufacturing Engineer Job Site:

9825 Spectrum Drive, Building 2, Suite 250, Austin, TX 78717

Minimum Requirements:

A master's degree in mechanical engineering, industrial engineering, or a related field (or foreign equivalent) and three (3) years of experience in the job offered, or as Design and Manufacturing Engineer, Project Engineer, or a related occupation.

Job Duties:

• Lead and manage significant engineering projects supporting sustaining operations and new product introductions.
• Develop, implement, and maintain manufacturing methods, process flows, work instructions, and production documentation.
• Define manufacturing requirements for components, subassemblies, and finished products.
• Estimate manufacturing costs, establish time standards, and recommend tooling and equipment requirements.
• Lead process development, optimization, and automation initiatives.
• Support capacity planning, line balancing, and scale-up activities.
• Serve as SME for manufacturing processes, equipment, and materials.
• Interface with Design Engineering to ensure manufacturability and alignment with product requirements.
• Lead design reviews and ensure design-for-manufacturability (DFM) principles are applied.
• Analyze test data to define process limits, specifications, and control strategies.
• Troubleshoot complex manufacturing issues using data-driven root cause analysis.
• Mentor and provide technical guidance to junior engineers and technical staff.
• Lead large-scale process improvement and new product introduction projects.
• Coordinate cross-functional teams to drive execution and resolve issues.
• Manage project timelines, deliverables, and technical documentation.
• Support capital equipment planning, justification, and onboarding.
• Ensure compliance with FDA, ISO, GMP, GLP, and GDP requirements.
• Lead or support: + Process, equipment, cleaning, and software validations + Test method development and validation + Risk assessments (FMEA, hazard analysis)
• Own or support deviation investigations, CAPAs, and nonconformance resolution.
• Participate in internal and external audits.
• Ensure documentation meets regulatory and company standards.
• Perform statistical analysis and process capability studies.
• Develop control charts and lead continuous improvement initiatives.
• Utilize MES, SAP, and other enterprise systems for manufacturing and quality tracking.
• Support implementation and optimizat.

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