Senior Engineering Manager

About TheraDep and Role Overview

TheraDep Technologies Inc. specializes in pioneering surface coating technologies for the MedTech and Life Sciences sectors. They are establishing a new Surface Coating Centre of Excellence in Youghal, County Cork, Ireland. The Senior Engineering Manager will play a pivotal role in this centre, overseeing the entire product lifecycle from conception to a validated production platform.

Key Responsibilities

• Manage the complete manufacturing process of TheraDep's Cold Atmospheric Plasma (BioDep) coating platforms, from initial specifications through full validation.
• Lead development efforts involving next-generation platforms incorporating robotics, automation, and integration of software.
• Direct the engineering quality management system (QMS) ensuring alignment with ISO 9001 and ISO 13485 standards accepted by MedTech clients and regulatory bodies.
• Prepare IQ/OQ/PQ qualification documentation for all platforms produced or implemented by TheraDep.
• Build and grow an engineering team consisting of 4 to 6 full-time employees by the end of the fiscal year 2027.

Required Qualifications and Experience

• Over 10 years of experience in automation, process engineering, or manufacturing of capital equipment preferably within MedTech or other regulated industries.
• Proven experience leading complex engineering platforms from design specifications to validated production stages.
• Expertise in creation and management of ISO 9001 and ISO 13485 compliant procedures.
• Experience authoring IQ/OQ/PQ protocols with a thorough understanding of internal and customer QA requirements.
• Academic degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or equivalent practical experience.