Production Manager

electroCore Inc•Rockaway, NJ

35d•Onsite

About The Position

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. The 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

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.
Strong managerial capabilities with deep understanding of medical device manufacturing documentation (i.e. DHR).
Knowledge of Design Controls.
Understanding of GMP (Good Manufacturing Practices).
Understanding of process engineering.

Nice To Haves

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

Responsibilities

Ensure all manufacturing processes adhere to FDA regulations and ISO 13485 quality standards by enforcing company WIs (Work Instructions) and SOPs (Standard Operating Procedures).
Maintain individual LOT documentation via device history records (DHR).
Recruit, train, and mentor production technicians.
Work with Quality team to maintain company’s quality standards and track defect rates.
Collaborate with Engineering team to help implement Lean manufacturing principles and process optimization strategies to increase yield, reduce waste, and enhance efficiency.
Coordinate closely with Supply Chain to ensure raw material availability.
Coordinate with Quality Assurance to resolve non-conformances.
Coordinate with Engineering for new product scale-ups.
Execute production schedules to meet customer demand and sales forecasts.
Manage manufacturing budgets, track scrap and rework rates, and control operational costs.