Tech Transfer Engineer

Responsibilities

• Execute end-to-end project management for company change projects, including planning, execution, risk management, and reporting.
• Create and manage Change Controls (CC), presenting them at the CC Review Board and driving activities to completion.
• Perform process validations, equipment qualifications, and method changes in accordance with regulatory and quality standards.
• Create and review Specifications, Standard Operating Procedures (SOPs), and Work Instructions.
• Execute validation and qualification protocols for production and test equipment.
• Assist with Root Cause Analysis (RCA) investigations and resulting Corrective and Preventive Actions (CAPA).
• Support risk assessments, mitigation strategies, and regulatory documentation to ensure compliance with FDA, ISO 13485, and MDR.
• Collaborate with Quality Assurance and cross-functional teams to ensure seamless updates to production processes and documentation.

Requirements

• Degree in engineering (process, manufacturing, mechanical, biomedical, or similar) or equivalent experience in the medical device industry.
• Proven experience in Project and Change Management within the medical device or life sciences industry.
• Experience working with Quality Management Systems (QMS) and Change Control frameworks.
• Knowledge of regulatory and safety standards such as ISO 13485, ISO 14971, or IEC 60601.
• Proficiency in project management tools (e.g., MS Project, Smartsheet).
• Familiarity with risk management tools such as FMEA and control plans.
• Strong understanding of formal engineering/process principles and manufacturing equipment.
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
• Willingness to travel occasionally (less than 10% of the time).

Preferred Qualifications

• Knowledge of process design and improvement methodologies such as Lean or Six Sigma (Green Belt preferred).
• Practical experience in the manufacture, release testing, and servicing of safety-critical devices.

Benefits

• Competitive compensation and comprehensive benefits package.
• Healthcare and retirement plans.
• Support for work-life balance.
• Opportunities for ongoing professional development.

About the Company

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. A pioneer in normothermic machine perfusion (NMP), OrganOx's flagship platform, the metra®, is used globally to keep donor organs in a metabolically active state, increasing the number of organs available for transplant. OrganOx is part of the Terumo Group.