CONTINUOUS IMPROVEMENT ANALYST III

Job Description

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Job Title: CONTINUOUS IMPROVEMENT ANALYST III

Posting Start Date: 7/8/26

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Description:

Job Overview

The NPD/NPI Industrial Engineer is responsible for developing, designing, and optimizing manufacturing systems for new medical products from the development stages through commercial production. This role collaborates with cross-functional teams to ensure products are manufacturable, scalable, and compliant with quality, regulatory, and business requirements.

Job Requirements

New Product Development (NPD)

• Participate in early product development phases to ensure Design for Manufacturability (DFM) and Design for Assembly (DFA) principles are incorporated.
• Evaluate manufacturing risks associated with product design.
• Provide cost analyses, capacity assessments, and operational requirements during product development.
• Collaborate with R&D to optimize product designs that improve productivity, quality, and ergonomics.
• Define manufacturing strategies for new medical devices.

New Product Introduction (NPI)

• Lead industrialization and new product launch activities.
• Develop production ramp-up plans.
• Coordinate pilot builds, engineering builds, and validation activities.
• Define labor, equipment, tooling, and facility requirements.
• Establish robust manufacturing processes for commercial production.

Manufacturing Planning

• Design manufacturing layouts for new production lines.
• Conduct capacity analyses and production flow modeling.
• Balance production lines and workstations.
• Determine takt time, cycle time, and required production capacity.

Cost Management

• Develop manufacturing cost models.
• Identify cost reduction opportunities during the product design phase.
• Evaluate capital investments (CAPEX) and justify projects through ROI analysis.

Product Transfers

• Lead product transfers between manufacturing sites or from development to production.
• Ensure operational continuity and adherence to project schedules.
• Coordinate documentation, training, and manufacturing readiness activities.

Quality and Regulatory Compliance

• Ensure compliance with:

• FDA 21 CFR Part 820

• ISO 13485

• GMP

• ISO 14971 (Risk Management)

• Participate in process validations:

• IQ (Installation Qualification)

• OQ (Operational Qualification)

• PQ (Performance Qualification)

• Support PFMEA, Control Plans, and risk management activities.

Continuous Improvement

• Apply Lean Manufacturing principles to new processes.
• Develop Standard Work for new operations.
• Lead productivity improvement initiatives during product launches.
• Implement visual management tools and operational control systems.

Data Analysis

• Analyze pilot build and pre-production data.

• Monitor launch metrics, including:

• Yield

• Scrap

• Throughput

• OEE (Overall Equipment Effectiveness)

• Productivity

• Utilize statistical tools to support data-driven decision-making.

What your background should look like

Education

Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.

Experience

5+ years of experience in medical device manufacturing.

Experience in New Product Development (NPD), New Product Introduction (NPI), or Product Transfer activities.

Proven involvement in new product launches from prototype through commercial production.

Technical Knowledge

Design for Manufacturability (DFM)

Design for Assembly (DFA)

Lean Manufacturing

Six Sigma

Process Development

PFMEA

Process Flow Mapping

Capacity Planning

Line Balancing

Validation (IQ/OQ/PQ)

SAP, Oracle, or equivalent ERP systems

Minitab, JMP, Advanced Excel, or Power BI

Key Competencies

Project Management

Cross-functional leadership and influence

Stakeholder Management

Strategic Thinking

Complex Problem Solving

Technical communication with R&D, Quality, and Operations teams

Risk Management

Competencies

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork

Job Locations:

Posting City: San Rafael

Job Country: Costa Rica

Travel Required: Less than 10%

Requisition ID: 155052

Workplace Type: Onsite

External Careers Page: Continuous Improvement

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