Senior Medical Device Production Lead

electroCore, Inc.; Rockaway (NJ); Híbrido; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

electroCore, Inc. is seeking a Manufacturing Leader to head all production activities for medical devices, ensuring safe, efficient manufacturing in full regulatory compliance with FDA and ISO 13485 standards.

You will drive Lean improvements, manage production scheduling and budgets, maintain device history records, and collaborate with Engineering, Quality Assurance and Supply Chain to meet daily KPIs.

Formación

• Bachelor's degree in Industrial/Mechanical Engineering, Operations Management, or related field preferred; or 8+ years in medical Class II device manufacturing.
• Production scheduling, budgeting, scrap/rework tracking, and cost control experience.
• Deep understanding of medical device documentation (DHR), Design Controls, GMP.
• Certifications such as GMP/ISO, PMP, Lean, or Six Sigma are highly preferred.
• Ability to stand/sit for long periods and lift up to 50 lbs.

Responsabilidades

• Lead all production activities to maximize throughput and minimize downtime.
• Ensure compliance with FDA regulations and ISO 13485 standards by enforcing WIs and SOPs and maintaining DHR.
• Recruit, train, and mentor production technicians and collaborate with Quality to maintain standards.
• Drive Lean manufacturing and process optimization to increase yield and efficiency.
• Coordinate with Supply Chain, Quality Assurance, and Engineering for cross-functional execution.

Conocimientos

Leadership

Project management

GMP knowledge

Design Controls

DHR documentation

Lean manufacturing

Six Sigma

PMP

Educación

Bachelor's degree in Industrial/Mechanical Engineering or Operations Management

Descripción del empleo

Description

This position is responsible for leading all production activities, ensuring medical devices are produced efficiently, safely, and in full compliance with global regulatory standards. This role minimizes downtime, maximizes throughput, and continuously optimizes assembly operations, while managing manufacturing personnel to achieve daily production targets.

Regulatory Compliance: Ensure all manufacturing processes adheres FDA regulations and ISO 13485 quality standards by enforcing company WIs (Work Instructions) and SOPs (Standard Operating Procedures). In

addition, maintains individual LOT documentation via device history records (DHR).

Team Leadership: Recruit, train, and mentor production technicians in working with Quality team to maintain company’s quality standards and track defect rates.

Continuous Improvement: Collaborate with Engineering team to help implement Lean manufacturing principles and process optimization strategies to increase yield, reduce waste, and enhance efficiency.

Cross-Functional Collaboration: Coordinate closely with Supply Chain to ensure raw material availability, with Quality Assurance to resolve non-conformances, and with Engineering for new product scale-ups.

Position is primarily responsible for managing the end-to-end manufacturing process of medical products, ensuring they are produced safely, efficiently, and in strict compliance with regulatory standards such as FDA and ISO 13485, while achieving production Key Performance Indicators (KPIs).

Requirements

Education: Bachelor’s degree in Industrial / Mechanical Engineering, Operations Management, or a related field is preferred; or a minimum of +8 years of progressive experience in medical Class II device manufacturing.

Production Scheduling: Execute production schedules to meet customer demand and sales forecasts. Manage manufacturing budgets, track scrap and rework rates, and control operational costs.

Technical proficiency: Strong managerial capabilities with deep understanding of medical device

manufacturing documentation (i.e. DHR), knowledge of Design Controls, understanding of GMP (Good Manufacturing Practices), and an understanding of process engineering.

Certifications: Certifications such as GMP/ISO standards, PMP (Project Management Professional), Lean Certified, or Six Sigma Black/Green Belt are highly preferred.

Standing/sitting for long periods of time (3-4 hours) and lifting packages up to 50 lbs.