Product Development & Manufacturing Engineering Manager

Halma plc

1d•Onsite

About The Position

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.

Requirements

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.
Excellent communication skills for coordinating with cross-functional teams, stakeholders, and clients.
Knowledge of safety standards, compliance requirements, and CI/CD tools.

Nice To Haves

Lean Six Sigma Certified desired.
Medical Device Regulations - ISO13485 is a Plus.

Responsibilities

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.
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.
Use Lean manufacturing, Six Sigma, and 5S tools to eliminate bottlenecks, improve workflow, and boost efficiency.
Conduct validation, testing, and commissioning of systems to ensure performance, safety, and compliance with regulations.
Create prototypes, develop verification/validation test protocols, and analyze data.
Create and maintain technical documentation, including schematics and user guides, Manufacturing Work Instructions, and train staff on new equipment.
Ensure compliance with ISO 13485 and FDA regulations, managing documentation for design history files (DHF) and validation.