Senior NPI Engineer

Senior NPI Engineer

Reporting To
Associate Director of Operations

Functional Area
Engineering / Operations / New Product Introduction (NPI)

Role Overview
The Senior NPI Engineer will support manufacturing and product development activities focused on innovative catheter-based technologies for the treatment of ischemic stroke.
The role will involve developing pilot manufacturing lines, transitioning manufacturing into controlled production environments, supporting external manufacturing partners, and managing ongoing operational activities. The successful candidate will play a key role in process development, design transfer, process validation, and manufacturing scale-up within a regulated medical device environment.

Key Responsibilities

• Manage the transfer of manufacturing processes to external manufacturing partners.
• Lead and support manufacturing and NPI engineers through training, mentoring, and technical guidance.
• Track, monitor, and improve internal and external operational metrics.
• Prepare project plans, technical specifications, and schedules for process and product development activities.
• Identify, evaluate, and collaborate with vendors regarding engineering materials, manufacturing processes, and equipment.
• Lead structured problem-solving activities relating to product and process challenges.
• Manage product cost activities for both internally and externally manufactured products.
• Lead the development and implementation of new manufacturing methods and technologies.
• Support and manage process verification and validation activities.
• Contribute to the development of company intellectual property.
• Participate in CAPA (Corrective and Preventive Action) activities relating to design and manufacturing processes.
• Support design transfer, process validation, and manufacturing readiness activities.
• Provide input into supplier selection and ongoing supplier performance evaluation.
• Design fixtures, models, and concepts for proof-of-concept development and verification/validation testing.
• Commit to continuous professional development to enhance both technical and non-technical competencies.

Qualifications & ExperienceEssential

• Bachelor’s Degree or higher in:
  
  • Mechanical Engineering
  • Biomedical Engineering
  • Materials Engineering
  • Plastics Engineering
  • or related discipline
• Minimum 3 years’ experience within the medical device industry, ideally in a manufacturing environment.
• Knowledge of relevant manufacturing processes and equipment.
• Experience using SolidWorks or equivalent CAD/modelling software.
• Strong understanding of process development, design transfer, and validation activities.
• Ability to rapidly develop device concepts, fixtures, and manufacturing solutions.
• Strong analytical and structured problem-solving skills.

Desirable

• Experience working with catheter-based or minimally invasive medical devices.
• Experience managing external manufacturing partners or CMOs.
• Experience within regulated environments (FDA / ISO 13485).

Quality & Training Requirements
QMS TrainingThis role requires completion of internal Quality Management System (QMS) training in accordance with SOP004-3 QMS Training Matrix.
Job-Specific TrainingAdditional role-specific training requirements will apply based on operational and project needs.

Key Competencies

• Technical problem solving
• Project management and planning
• Cross-functional collaboration
• Communication and stakeholder management
• Process development and optimisation
• Continuous improvement mindset
• Attention to detail and regulatory compliance