Job Summary

The Engineer III serves as a senior technical contributor responsible for the design, development, validation, optimization, and lifecycle support of Class I and Class II medical devices and their associated manufacturing, packaging, and sterilization processes. This role combines product design and development expertise with manufacturing and process engineering leadership to support new product introductions, product improvements, and operational excellence initiatives.  

The Engineer III is responsible for concept development, requirements generation, prototype fabrication, assembly and component design, engineering analysis, design transfer, process validation, and manufacturing readiness activities. The position partners closely with R&D, Quality, Regulatory Affairs, Supply Chain, and Operations to ensure products are designed for manufacturability, scalability, quality, and regulatory compliance.  

This role is expected to act as a technical lead with minimal supervision, utilizing creativity, technical judgment, and cross-functional leadership to deliver projects on time, on quality, and within budget. 

Essential Job Functions 

Responsibilities: 

• Perform the design, development, implementation, and analysis of systems, products, assemblies, and components that meet specified requirements.  
• Lead concept development, requirements generation, prototype fabrication, and product design activities for new and existing medical devices.  
• Utilize CAD software to create and modify 3D components, assemblies, and engineering drawings in accordance with company and industry standards.  
• Perform engineering analyses and design reviews to ensure product performance, reliability, manufacturability, and compliance with applicable requirements.  
• Execute and support design verification and validation activities.  
• Develop and maintain engineering documentation including design specifications, Bills of Materials, Design History Files, risk management files, engineering change orders, and design transfer documentation.  
• Participate in supplier selection, evaluation, and technical oversight of external manufacturers and development partners. 
• Lead the development, qualification, validation, optimization, and sustainment of manufacturing processes for medical devices. 
• Support manufacturing scale-up, line balancing, capacity planning, and production readiness activities.
• Develop and maintain manufacturing procedures, work instructions, process specifications, and standard operating procedures. 
• Author, execute, and approve equipment, process, packaging, and sterilization validation protocols and reports. 
• Conduct process characterization studies and process capability analyses to improve quality, throughput, and cost performance. 
• Lead root cause investigations and implement corrective and preventive actions (CAPA) related to product and process performance 
• Managing the maintenance plan of the production lines 
• Lead multiple engineering projects simultaneously, ensuring execution within scope, budget, and timeline requirements. 
• Provide technical guidance and mentoring to engineers, technicians, and project team members. 

Qualifications

Requirements: 

• 7+ years of engineering experience in the medical device industry. 
• Demonstrated experience in both product design/development and manufacturing/process engineering. 
• Experience working within ISO 13485 regulated environments. 
• Experience with process validation (IQ/OQ/PQ), manufacturing process development, and continuous improvement methodologies 
• Experience with risk management tools including FMEA and PFMEA. 
• Strong analytical, troubleshooting, and problem-solving skills. 
• Knowledge of medical device manufacturing processes, materials, and assembly methods 
• Working knowledge of packaging and sterilization validation requirements preferred 
• Experience with design controls, risk management, verification, validation, and design transfer. 
• Ability to balance speed, quality, compliance, and business objectives while managing multiple priorities 
• Excellent oral and written communication skills in both Hebrew and English 

Competencies

Demonstrates ownership and accountability; the ability to plan, execute, control, and deliver; communicate effectively both written and verbal; lead and influence others without direct authority; solve complex technical problems; make sound decisions with imperfect information; manage competing priorities; and drive cross-functional collaboration to achieve project and business objectives. 

Physical Requirements

Performing the duties of this job regularly involves: sitting, hearing/listening, repetitive hand movement, vision requirements - close vision, adjust focus, color code 

Mental Requirements

This position requires the ability to: maintain an appropriate work pace; comprehend and follow instructions; exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; problem solve, make decisions; count and compute, analyze and interpret data; multi-task/re-direct; experience numerous interruptions. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations. 

Other Requirements

Minimal business travel required, less than 15% of the time; must fit within the Safeguard Medical culture 

Work Environment

The noise level in the work environment is usually; (1) quiet to moderate 

This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned, and activities may change at any time with or without notice.