CONTINUOUS IMPROVEMENT ANALYST III (San Rafael, A, CR, 20108)

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. <div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Job Overview</b></H2> </div><div><p>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.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Job Requirements</b></H2> </div><div><div> <h2>New Product Development (NPD)</h2> <ul> <li>Participate in early product development phases to ensure <strong>Design for Manufacturability (DFM)</strong> and <strong>Design for Assembly (DFA)</strong> principles are incorporated.</li> <li>Evaluate manufacturing risks associated with product design.</li> <li>Provide cost analyses, capacity assessments, and operational requirements during product development.</li> <li>Collaborate with R&amp;D to optimize product designs that improve productivity, quality, and ergonomics.</li> <li>Define manufacturing strategies for new medical devices.</li> </ul> <h2>New Product Introduction (NPI)</h2> <ul> <li>Lead industrialization and new product launch activities.</li> <li>Develop production ramp-up plans.</li> <li>Coordinate pilot builds, engineering builds, and validation activities.</li> <li>Define labor, equipment, tooling, and facility requirements.</li> <li>Establish robust manufacturing processes for commercial production.</li> </ul> <h2>Manufacturing Planning</h2> <ul> <li>Design manufacturing layouts for new production lines.</li> <li>Conduct capacity analyses and production flow modeling.</li> <li>Balance production lines and workstations.</li> <li>Determine takt time, cycle time, and required production capacity.</li> </ul> <h2>Cost Management</h2> <ul> <li>Develop manufacturing cost models.</li> <li>Identify cost reduction opportunities during the product design phase.</li> <li>Evaluate capital investments (CAPEX) and justify projects through ROI analysis.</li> </ul> <h2>Product Transfers</h2> <ul> <li>Lead product transfers between manufacturing sites or from development to production.</li> <li>Ensure operational continuity and adherence to project schedules.</li> <li>Coordinate documentation, training, and manufacturing readiness activities.</li> </ul> <h2>Quality and Regulatory Compliance</h2> <ul> <li> <p>Ensure compliance with:</p> <ul> <li>FDA 21 CFR Part 820</li> <li>ISO 13485</li> <li>GMP</li> <li>ISO 14971 (Risk Management)</li> </ul> </li> <li> <p>Participate in process validations:</p> <ul> <li>IQ (Installation Qualification)</li> <li>OQ (Operational Qualification)</li> <li>PQ (Performance Qualification)</li> </ul> </li> <li> <p>Support PFMEA, Control Plans, and risk management activities.</p> </li> </ul> <h2>Continuous Improvement</h2> <ul> <li>Apply Lean Manufacturing principles to new processes.</li> <li>Develop Standard Work for new operations.</li> <li>Lead productivity improvement initiatives during product launches.</li> <li>Implement visual management tools and operational control systems.</li> </ul> <h2>Data Analysis</h2> <ul> <li> <p>Analyze pilot build and pre-production data.</p> </li> <li> <p>Monitor launch metrics, including:</p> <ul> <li>Yield</li> <li>Scrap</li> <li>Throughput</li> <li>OEE (Overall Equipment Effectiveness)</li> <li>Productivity</li> </ul> </li> <li> <p>Utilize statistical tools to support data-driven decision-making.</p> </li> </ul> </div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>What your background should look like</b></H2> </div><div><p>Education<br>Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.<br>Experience<br>5+ years of experience in medical device manufacturing.<br>Experience in New Product Development (NPD), New Product Introduction (NPI), or Product Transfer activities.<br>Proven involvement in new product launches from prototype through commercial production.<br>Technical Knowledge<br>Design for Manufacturability (DFM)<br>Design for Assembly (DFA)<br>Lean Manufacturing<br>Six Sigma<br>Process Development<br>PFMEA<br>Process Flow Mapping<br>Capacity Planning<br>Line Balancing<br>Validation (IQ/OQ/PQ)<br>SAP, Oracle, or equivalent ERP systems<br>Minitab, JMP, Advanced Excel, or Power BI<br>Key Competencies<br>Project Management<br>Cross-functional leadership and influence<br>Stakeholder Management<br>Strategic Thinking<br>Complex Problem Solving<br>Technical communication with R&amp;D, Quality, and Operations teams<br>Risk Management</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px"><b>Competencies</b></H2> </div><div><div>Values: Integrity, Accountability, Inclusion, Innovation, Teamwork</div></div></div></div>