Production Supervisor

Supira Medical, Inc.

Los Gatos (CA)

On-site

USD 83,000 - 90,000

Full time

8 days ago

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Benefits offered by this job

Equity
Benefits

Job summary

Supira Medical, Inc. is seeking a Production Supervisor to lead the daily manufacturing of our pVAD devices. You will supervise direct reports and coordinate with engineering, quality, and management to drive safety, quality, yield and throughput.

The role reports to the Sr. Manufacturing Manager and requires 8+ years in medical device manufacturing with at least 2 years in supervision. Strong GMP knowledge and leadership are essential for success in a fast-paced, compliant environment.

Qualifications

  • 8+ years of direct experience in manufacturing, production, assembly, or operations within medical device.
  • 2+ years of supervisory 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.

Responsibilities

  • Lead, plan, organize, and direct daily production activities to meet quality and business goals.
  • Balance lines, monitor workflow, staffing, and resources for efficient production plans.
  • Communicate schedule status, risks, and performance to engineering, quality, supply chain, and management.
  • Conduct regular Gemba walks to identify opportunities for safety, quality, and productivity improvements.
  • Recommend and implement productivity and yield improvements.
  • Issue LHRs for final assembly production and review for completeness with Quality.
  • Support engineering changes, process improvements, validations, and new product introductions.
  • Ensure manufacturing activities comply with GMP, quality, safety, and documentation requirements.
  • Maintain a safe, audit-ready manufacturing environment and proper housekeeping.

Skills

Leadership
Communication
Problem solving
GMP knowledge
Medical device manufacturing

Job description

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.

Description:

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.

Responsibilities, Skills & Hands-On Experience:
  • 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.
Education & Work Experience:
  • 8+ years of direct experience in manufacturing, production, assembly, or operations environment within medical device.
  • 2+ years of previous supervisory 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.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $83,200 to $90,000 + equity + benefits.

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