Product Development & Manufacturing Engineering Manager

Job Summary

The Product Development & Manufacturing Engineering Manager has a hands-on role that leads a team to design, implement, and optimize automated manufacturing systems and processes, improving efficiency and reducing costs. This position is on-site in Vista, CA.

Key Responsibilities

• Metallurgical Processing & Integration: Combines chemical engineering principles with metallurgy to design, optimize, and manage metal production, treating raw materials to create high-value metal products and incorporates into plastic for the next assembly.
• Design and Prototyping: Create high-quality 3D CAD models, drawings, and 2D blueprints using SolidWorks or similar software, focusing on design for manufacturability (DFM). Create prototypes, develop verification/validation test protocols, and analyze data. Part creation by way of 3D printing will be required.
• Process Improvement & Optimization: Use Lean manufacturing, Six Sigma, and 5S tools to eliminate bottlenecks, improve workflow, and boost efficiency.
• Testing & Troubleshooting: Conduct validation, testing, and commissioning of systems to ensure performance, safety, and compliance with regulations.
• Prototyping & Testing: Create prototypes, develop verification/validation test protocols, and analyze data.
• Documentation & Training: Create and maintain technical documentation, including schematics and user guides, Manufacturing Work Instructions, and train staff on new equipment.
• Quality & Compliance: Ensure compliance with ISO 13485 and FDA regulations, managing documentation for design history files (DHF) and validation.

Required Skills & Qualifications

• Bachelor’s degree in Engineering (Metallurgical, Mechanical, or equivalent experience)
• 3–10 years of product development and/or Manufacturing engineering in a regulated industry (medical devices preferred).
• Proficiency in CAD software (e.g., SolidWorks), GD&T, and knowledge of materials (plastics, metals) used in medical devices.
• Automation & manufacturing systems (specification, commissioning, troubleshooting)
• New Product Introduction (NPI) and design for manufacturability (DFM)
• Cross-functional leadership, project management, and technical communication
• Strong critical thinking and analytical skills to resolve complex technical issues during production. Lean Six Sigma Certified desired.
• Excellent communication skills for coordinating with cross-functional teams, stakeholders, and clients.
• Knowledge of safety standards, compliance requirements, and CI/CD tools. Medical Device Regulations - ISO13485 is a Plus.

Work Environment

Product development, prototyping, and manufacturing settings and offices (Automation and Chemical for metal processing).

Key Performance Indicators (KPIs)

• Engineering PDP/NPI Project schedule and budget adherence
• Machine/System uptime and reliability.
• Automation adoption rate and efficiency gains.
• Overall Equipment Effectiveness (OEE).
• Cycle time reduction and production throughput.
• Cost reduction (operational and material costs).