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Production Engineering Supervisor

2 months ago

Austin, Texas, United States ICU Medical Full time

Position Overview

The Manufacturing Supervisor plays a crucial role in leading and providing technical guidance to ensure the development of efficient and effective processes that facilitate the production of high-quality medical devices in accordance with engineering standards, regulatory requirements, and industry best practices. This individual will oversee a team of technical staff and will be instrumental in projects focused on scaling production and enhancing manufacturing capabilities.

Key Responsibilities

· Ensure seamless production operations and address any disruptions promptly. Conduct thorough root cause analyses for any non-conformities 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, targeting improvements in yield, reduction of scrap, minimizing MUV, optimizing cycle times, addressing ergonomic concerns, and fulfilling maintenance requirements.

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

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

· Provide leadership and direction for complex issues that require significant judgment in the evaluation, selection, and adaptation of standard engineering methodologies, procedures, and criteria.

· Engage with suppliers and internal departments to secure necessary resources, resolve inter-departmental conflicts, and contribute to the overall objectives of the organization.

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

· Conduct project and team meetings to address challenges, assess current progress, share information, and evaluate changes in priorities.

· Supervise the preparation of documentation related to engineering activities, including schematics, 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 duties as assigned or required.

Required Knowledge & Skills

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

· Familiarity with Lean methodologies to enhance equipment and process efficiencies.

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

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

· In-depth knowledge of material strength, kinematics, dynamics, vibration, fluid dynamics, automation, plastic injection molding, assembly processes, fixturing, testing, and process control techniques.

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

· Strong analytical and problem-solving 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 management, supervisory, or leadership capacity.

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