Senior Manufacturing Engineer

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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...