Leo Cancer Care, Inc., New Product Introduction (NPI) Engineer, Level III-IV

Position Title: New Product Introduction (NPI) Engineer, Level III-IV

Reports To: Senior Manager_Global Hardware Engineer

Type: Full-time, Hybrid

Position summary:

At Leo Cancer Care, the New Product Introduction Engineer (NPI Engineer) plays a pivotal role in bringing innovative cancer care solutions from concept to reality. This position leads and coordinates the successful design transfer of new products, process improvements, upgrades, or changes from design and development into manufacturing and service. The NPI Engineer ensures seamless integration into production, supply chain, and service processes, maintaining a strong focus on quality, compliance, and efficiency.

Knowledge and Skill Requirements

• Bachelor's degree (or experience equivalent) in Engineering, Science, or a related technical discipline
• Demonstrated experience in project leadership or coordination within engineering or manufacturing
• Experience working in regulated industries; medical device experience strongly preferred (ISO13485, FDA, MDR)
• Proven experience managing New Product Introductions, including pilot builds and process validation
• Strong background in continuous product improvements (reliability, manufacturability, and serviceability)
• Proficiency with engineering practices: design reviews, DFM (Design for Manufacturability), DFS (Design for Serviceability), life testing, etc.
• Hands-on experience with CAD/PLM tools (SolidWorks, PDM) and ERP systems (controlling drawings, designs, BOMs, parts, and work instructions)
• Excellent interpersonal, communication, and relationship management skills.
• Strong analytical and problem-solving skills
• The ability to travel to customer sites and suppliers as needed
• Strong organizational skills and attention to detail.
• Ability to work effectively in a fast-paced, cross-functional team environment.

Primary Responsibilities

Design Transfer Leadership

• Lead NPI workstreams, ensuring smooth transition from R&D to production and service.
• Coordinate resources, schedules, and deliverables across teams.

• Monitor and report project progress, risks, and issues; escalate when appropriate.

Manufacturability & Serviceability

• Ensure DFM and DFS practices are embedded in projects.
• Support structured make-vs-buy decision-making using data-driven analysis.

• Collaborate with supply chain and vendors to qualify new components and assemblies.

Change & Configuration Management

• Drive effective implementation of Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs).
• Act as change package leader/coordinator, ensuring complete documentation, testing, impact assessments, and effectiveness checks.
• Own product configuration management from pre-release through release (parts, BOMs, and procedures).

Continuous Improvement

• Apply Lean methodologies to refine the design transfer process, checklists, and workflows.
• Drive lessons learned and feedback loops from prior NPI launches.

• Identify opportunities to enhance efficiency, quality, and compliance in design transfer

Knowledge Sharing & Capability Building

• Share knowledge, tools, and best practices across the organization.
• Coach and support team members in NPI and design transfer principles
• Maintain up-to-date skills in project management, design transfer, and problem-solving tools and techniques.

For reference: NPI Engineer vs Manufacturing Engineer

Aspect

NPI Engineer (New Product Introduction)

Manufacturing Engineer

Primary Focus

Transitioning designs into scalable, compliant production & service

Optimizing and sustaining ongoing production

Lifecycle Stage

Early-phase (concept pilot builds release)

Steady-state production (post-release)

Key Responsibilities

• Design for Manufacturability & Serviceability
• Develop/validate new processes, tooling, and test equipment
• Create work instructions, SOPs, and training
• Lead pilot builds & process validation
• Drive issue resolution during product transfer

• Maintain and improve existing processes
• Troubleshoot equipment, process, operator issues
• Implement lean/Kaizen for cost & efficiency
• Ensure ISO13485/FDA compliance daily
• Support CAPA and root cause analysis
• Manage tooling, fixtures, equipment upkeep

Deliverables

• Build change packages
• Validated processes
• Coordinate design transfer activities

• Reliable day-to-day operations
• Cost reduction and yield improvements
• Continuous improvement initiatives
• Reduced downtime & scrap

Metrics (Examples)

• Time to stable production
• First-pass yield during pilot
• # of ECOs post-transfer
• Cost of Poor Quality (CoPQ) at launch

• Overall Equipment Effectiveness (OEE)
• Line throughput & takt time
• Scrap/rework rates
• Labor efficiency
• Downtime reduction

Mindset

Project-based, milestone-driven

Operations-based, process-driven

Cross-Functional Work

R&D, Quality, Supply Chain, Operations

Production, Quality, Supply Chain, Service

About Leo Cancer Care

Leo Cancer Care is helping make changes in Radiation Therapy by shifting to upright patient positioning, imaging, and treatment. We do what we do to find a better way - a better way to treat cancer and create a paradigm shift in radiation therapy that benefits all. We will achieve this by enhancing the accessibility and quality of medicine in cancer care globally, thereby making cancer treatment a more human experience for all.

Working in radiotherapy, not only will you be driving change for the greater good, but you'll also be working on products that span a wide range of different disciplines.

Ways of Working

Leo Cancer Care is committed to cultivating a diverse and inclusive work environment. We embrace and celebrate the unique backgrounds, experiences, and perspectives of all individuals. We believe that diversity enriches our organization and strengthens our ability to innovate and excel. Discrimination or harassment of any kind will not be tolerated. We encourage all qualified candidates to apply and join us in our mission to create a respectful and equitable workplace for all. Leo Cancer Care is an equal opportunity employer.