Job Description

Job Description

Key Responsibilities

1. PFMEA & Control Plan Development

• Lead cross-functional PFMEA workshops, calculate RPNs, implement controls, and document action plans.
• Ensure recommended corrective and preventive actions are developed, tracked, verified, and integrated into Control Plans for sustainable impact.

2. Root-Cause Analysis & CAPA

• Trigger RCA protocols (e.g., 5‑Whys, Fishbone, 8D) in response to SPC alerts, QC escapes, scrap, or assembly issues.
• Clearly define problem statements, investigate timeline and contributing factors, and execute cross-functional RCA sessions .
• Develop SMART corrective/preventive actions with clear ownership, deadlines, and verification through trial runs, audits, and SPC.
• Monitor CAPA effectiveness and update documentation, work instructions, PFMEA, Control Plans, and training based on outcomes.

3. New Product Introduction & Capital Equipment Integration

• Design and implement manufacturing processes for new products, working closely with design engineering and Integrated Product Teams.
• Lead equipment procurement, installation, qualification, and release into production.
• Validate new processes via First Article Inspections and ensure software systems reflect all CAPA-driven updates.

4. Data Analysis & Process Capability

• Track key process metrics (Cp/Cpk, SPC), identify trends, and trigger RCA when performance dips or escapes occur.
• Propose and execute projects targeting cost reduction and defect prevention, backed by data.

5. Shop-Floor Optimization & Documentation

• Partner with hourly workforce, tool designers, QA, systems, and assembly teams to apply CAPA-driven process improvements, reducing QC/PC escapes and assembly cost.
• Maintain and update work instructions, SOPs, tooling specs, and QAD/process control documentation to reflect RCA outcomes. Familiarity with technical data such as blueprints, quality documents, specs, etc.
• Provide operational engineering/quality support to minimize production downtime and improve cost, delivery, quality and assist with problem solving during manufacturing related investigations.

6. EH&S & Ergonomics Leadership

• Support all EH&S initiatives by driving safe processes across all production product lines. Proactively identify environmental, ergonomic, and human factor risks.
• Drive RCA and implement corrective/preventive actions to eliminate root causes of incidents or near misses.

7. Lean Manufacturing & Continuous Improvement

• Actively participate in CORE/lean initiatives (e.g., Kaizen, 5S, Gemba), applying root-cause tools throughout.
• Sustain improvements via iterative RCA and CAPA integration.

8. Collaboration & Coaching

• Work closely with QA, IS, IPT, systems designers, and program assembly partners.
• Mentor team members on RCA and CAPA methodologies to build organizational problem-solving capability.

Qualifications

• Bachelor’s degree in Engineering (mechanical, industrial, manufacturing, or related) + 1–5 years of manufacturing/process/quality engineering experience.
• Proven experience with PFMEA, Control Plan development, SPC, RCA (5‑Whys, Fishbone, 8D), and CAPA implementation.
• Proficient in office software (Excel, Word, PowerPoint, Outlook) and familiarity with manufacturing/PFMEA systems.
• Strong analytical and problem-solving mindset with the ability to lead investigations and deliver corrective actions.
• Excellent communication and collaboration skills across multiple teams.
• U.S. Citizenship required for government contract access.

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