Production Supervisor

Shifamed•Los Gatos, CA

28d•Onsite

About The Position

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. As the Production Supervisor at Supira, you will play a critical role in ensuring the successful manufacturing and development of our medical devices. This role will have direct reports and serves as a key liaison between production, engineering, quality and management to drive effective manufacturing, solve production challenges and maintain compliance with applicate quality systems requirements. The production supervisor is responsible for production performance with respect to safety, quality, yield and throughput, and leading the day-to-day activities of direct reports. Reporting to the Sr. Manufacturing Manager, you will collaborate with cross-functional teams to drive innovation, uphold industry standards, and foster a culture of excellence.

Requirements

8+ years of direct experience in manufacturing, production, assembly, or operations environment within medical device.
2+ years of previous supervisoory leadership experience in medical device manufacturing or related field.
Experience leading or supervising manufacturing teams and supporting daily production operations.
Experience managing production schedules, staffing requirements, workflow prioritization, and operational performance.
Experience with GMP, quality systems, deviation management, nonconformance processes and regulatory compliance requirements.
Strong leadership, conflict resolution, and employee relations skills.
Proficiency with Microsoft office applications.
Strong verbal and written communication and interpersonal abilities
Ability to work effectively within a team in a fast-paced changing environment.

Responsibilities

Responsible for leading, planning, organizing, and directing all daily activities for the production team to ensure all production requests, quality requirements business goals are achieved.
Balance lines, monitor workflow, production performance, staffing levels, and resource allocation to ensure efficient execution of production plans.
Communicate schedule status, risks, areas of improvement, scrap, and performance to engineering, quality, supply chain, and management.
Conduct regular Gemba walks, monitor daily performance and identify opportunities to improve safety, quality, delivery, and productivity.
Recommend and implement productivity and yield improvements.
Issue LHRs to the manufacturing floor for final assembly production.
Review LHRs for completeness and accuracy; resolve issues with Quality.
Support implementation of engineering changes, process improvement and validations, and introduction of new product.
Ensure manufacturing activities are performed in compliance with GMP, quality, safety, and documentation requirements.
Maintain a safe, compliant and audit ready manufacturing environment.
Maintain work area cleanliness and compliance with various safety, fire, and hazmat guidelines.
Provide coaching, mentoring, performance feedback, and development opportunities to support employee growth and performance.
Recruit, hire and set up training qualification programs for new and current hires.
Ensure employees receive appropriate onboarding, training, qualification, and cross-training to maintain workforce flexibility and operational continuity.
Write and conduct performance reviews, hold performance discussions, address performance concerns, and administer corrective actions in accordance with company policies and procedures.
Support recruiting, interviewing, onboarding and workforce planning activities to maintain appropriate staffing levels.
Perform other duties as assigned.