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Production Operations Supervisor

2 months ago

Austin, Texas, United States ICU Medical Full time

Position Overview

The Manufacturing Supervisor plays a crucial role in guiding and providing technical expertise to ensure the production of high-quality medical devices that adhere to engineering specifications, FDA regulations, and GMP standards. This position involves overseeing a team of technical professionals and is pivotal in projects related to scaling production and managing high-volume manufacturing processes.

Key Responsibilities

· Ensure the smooth operation of manufacturing processes and support production continuity. Lead root cause analysis for any non-conformance issues and implement long-term corrective actions and preventive strategies. Assess and rectify systemic challenges.

· Collaborate with Manufacturing and Maintenance teams to enhance the performance of production systems, focusing on yield improvements, scrap reduction, cycle time optimization, ergonomic enhancements, and maintenance requirements.

· Drive initiatives for continuous improvement and lean manufacturing practices. Evaluate yield challenges and advocate for the design and selection of equipment that minimizes costs while enhancing quality.

· Oversee all phases of various engineering projects. Foster the achievement of organizational goals through effective team leadership.

· Provide guidance and leadership for complex problems that require significant judgment in the evaluation, selection, and adaptation of standard engineering methodologies, techniques, and criteria.

· Coordinate with vendors and internal departments to secure necessary resources, resolve inter-departmental conflicts, and contribute to the organization's objectives.

· Directly manage a team of Engineers and technical staff, prioritizing tasks based on business needs and resource availability.

· Conduct project and team meetings to address issues, assess current status, provide updates, and evaluate changes in priorities.

· Supervise the preparation of documentation related to engineering activities, including drawings, validation and capability testing, and various operating procedures. Prepare reports and presentations for management as necessary.

· Develop timelines and milestones to ensure projects are completed on schedule and within budget.

· Exemplify company values and support strategic initiatives.

· Perform additional related duties as assigned or required.

Required Knowledge & Skills

· Proficiency in Six Sigma methodologies (DOE, Process Capability, Gage R&R, etc.).

· Expertise in Lean methodologies to enhance equipment and process efficiencies.

· Familiarity with SolidWorks and experience with ASME Y14.5, ISO, and GD&T standards.

· Comprehensive understanding of the clinical applications and risks associated with the product.

· Strong grasp of material strength, kinematics, dynamics, vibration, fluid dynamics, automation, plastic injection molding, assembly processes, fixturing, testing, and process control techniques.

· Knowledge of the Medical Device Industry and familiarity with relevant regulations.

· Exceptional problem-solving and analytical skills.

Minimum Qualifications, Education & Experience

· Bachelor's Degree in Engineering or Technology; a Master's degree or MBA is preferred.

· A minimum of 10 years of experience in Medical Device Engineering or Technology.

· At least 5 years in a supervisory or leadership capacity.

· Strong background in injection molding, tooling, and automation.