Sr. Manufacturing Engineer

Position Title: Sr. Manufacturing Engineer

Work Location: Austin TX USA 78759

Assignment Duration: 12 Months

Work Arrangement: Onsite

Position Summary: Plan, implement, and manage engineering projects for automated assembly lines, including development, build, testing, commissioning, and validation. Manage complex automation engineering projects and new product development across multiple global sites.

Key Responsibilities:

* High Priority: Plan, implement, and manage engineering projects for automated assembly lines, including development, build, testing, commissioning, and validation.

* High Priority: Manage complex automation engineering projects and new product development across multiple global sites

* Drive activities with equipment suppliers to ensure successful production start-up and scale-up.

* Lead design, planning, and sustaining of automated manufacturing systems.

* Ensure adherence to quality, regulatory, and corporate standards; report progress against timelines.

* Identify and escalate risks impacting project delivery, product quality, or safety.

* Interface with cross-functional teams including R&D, Quality, Regulatory, and Operations.

* Develop and implement innovative solutions and manage engineering changes.

* Conduct complex engineering studies, analyze data, and prepare technical reports.

* Create process documentation and technical procedures for medical device equipment.

* Perform root cause analysis and implement corrective actions for yield and cycle time issues.

* Travel up to 10% (primarily Europe and U.S.) for project-related activities.

Qualification & Experience:

* Prior experience in medical device or pharmaceutical environments (FDA/cGMP/ISO regulated).

* Strong knowledge of automation systems, validation lifecycles, and high-volume manufacturing lines.

* Excellent project management, communication, and problem-solving skills.

* Bachelor's degree in Engineering/Manufacturing or related discipline (Automation/Electronics/Mechatronics preferred).

* Minimum 5+ years of progressive technical experience; experience with automated manufacturing processes preferred.

* Ability to work independently and in a fast-paced, team-oriented environment.

* Familiarity with equipment software, pneumatics, electronics, vision systems, lasers, and GAMP guidelines.

Working Conditions & Physical Demands (If Applicable): Travel up to 10% (primarily Europe and U.S.) for project-related activities.