Location: Irvine, California
Experience: 6-8 Years
Industry: Medical Devices / Healthcare
We are seeking an experienced Senior Electromechanical Design Engineer to support New Product Development (NPD), equipment design, and manufacturing automation initiatives within the medical device industry. The ideal candidate will have hands-on experience in electromechanical system design, mechanical CAD, automation, PLC programming, and product/process validation, along with a strong understanding of medical device quality and regulatory standards.
Identify, design, and develop equipment and tooling required for new product development.
Design and develop electromechanical systems, mechanical components, fixtures, and automation equipment.
Integrate mechanical and electrical components to deliver reliable system performance.
Identify and implement suitable stepper motors, motor drivers, sensors, and PLC-based control solutions.
Evaluate existing manufacturing processes and implement improvements to support new products.
Develop and implement automation solutions for manufacturing processes, equipment, and tooling.
Prepare, maintain, and manage engineering specifications, design documentation, and technical records.
Perform product and process validation activities to ensure compliance with engineering and quality requirements.
Ensure equipment designs meet applicable safety, environmental, and manufacturing requirements.
Provide technical guidance to technicians and engineers in resolving complex design and equipment issues.
Coordinate and technically review the work of a small group of technicians, as required.
Support equipment procurement, installation, testing, commissioning, and qualification activities.
Collaborate with cross-functional teams, including R&D, manufacturing, quality, and regulatory functions.
Communicate project progress, technical risks, and business opportunities to management.
Electromechanical Design: Experience designing and developing electromechanical systems, equipment, and components.
New Product Development (NPD): Knowledge of product development processes, design engineering, and product lifecycle activities.
CAD & Mechanical Design: Strong hands-on experience with SolidWorks or equivalent 3D CAD software.
Industrial Automation: Knowledge of PLC programming, stepper motors, motor drivers, sensors, and automation systems.
System Integration: Experience integrating mechanical, electrical, and control components.
GD&T: Strong understanding of Geometric Dimensioning and Tolerancing and engineering drawings.
Medical Device Industry: Experience with medical device development, manufacturing processes, or regulated engineering environments.
Quality & Regulatory: Knowledge of Good Manufacturing Practices (GMP), ISO 13485, and applicable medical device regulatory standards.
Validation: Experience supporting product/process validation and maintaining engineering documentation.
Experience in robotics, industrial automation, precision instruments, or automated manufacturing equipment.
Knowledge of Medical Device Directive (MDD) and Medical Device Regulation (MDR).
Experience with Design of Experiments (DOE), statistical analysis, and process optimization.
Experience in fixture design, equipment development, and manufacturing process improvement.
Familiarity with project planning tools such as Microsoft Project.
Strong proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
6-8 years of relevant engineering experience.
Minimum 5 years of medical device industry experience; 5-8 years is preferred.
Demonstrated knowledge of both New Product Development (NPD) and automation.
Strong electromechanical design and CAD skills.
Knowledge of SolidWorks, GD&T, and mechanical/electrical system integration.
Willingness to relocate to Irvine, California.
