Electro-Mechanical / New Product Development Engineer

Job Description – Electro-Mechanical / New Product Development Engineer

• Job Title: Electro-Mechanical / New Product Development Engineer
• Location: Irvine, CA
• Duration: 6 months
• GBaMS ReqID: 10943734
• Experience Required: 6–8 years
• Primary Skills: Electro-Mechanical Design, New Product Development, SolidWorks, CAD, GD&T, PLC, Automation
• Industry: Medical Devices / Pharmaceutical
• Essential Skills: Medical Device & Regulations
• Desirable Skills: New Product Introduction (NPI) / Product Engineering

Role Summary

• Design and develop electro-mechanical systems and components for new product development.
• Perform system integration of mechanical and electrical components.
• Support automation implementation in manufacturing processes and tooling.
• Work on product and process improvements with limited supervision.
• Apply engineering judgment to developmental design activities.
• Support product validation, process validation, and equipment development.
• Experience with industrial automation, robotics, or precision instruments is preferred.

Technical Skills

• Strong experience with SolidWorks and CAD software.
• Strong understanding of Geometric Dimensioning & Tolerancing (GD&T).
• Experience designing electro-mechanical systems and components.
• Knowledge of:
  • Stepper motors
  • Motor drivers
  • Sensors
  • PLC programming
• Experience with industrial automation and robotics is a plus.
• Knowledge of good manufacturing practices (GMP).
• Experience with engineering documentation and specifications.
• Knowledge of statistical analysis and Design of Experiments (DOE) is preferred.
• Strong computer skills and proficiency with Microsoft Office tools.

Medical Device & Regulatory Knowledge

• Knowledge of medical device manufacturing and documentation.
• Understanding of ISO 13485.
• Knowledge of medical device regulatory standards.
• Familiarity with:
  • MDD – Medical Device Directive
  • MDR – Medical Device Regulation
• Understanding of product and process validation requirements.
• Experience working in a regulated medical/pharmaceutical environment preferred.

New Product Development / NPI

• Knowledge and experience in Product Development / New Product Development (NPD).
• Experience supporting New Product Introduction (NPI) activities.
• Identify, design, and develop equipment required for new product development.
• Study existing processes and implement improvements for new products.
• Implement automation within processes and tooling.
• Prepare and manage engineering specifications.
• Support product and process development activities.
• Participate in validation activities.

Key Responsibilities

• Identify, design, and develop equipment required for new product development.
• Design and integrate mechanical and electrical components.
• Develop electro-mechanical solutions for manufacturing and product applications.
• Evaluate existing processes and recommend improvements.
• Implement automation solutions in processes and tools.
• Identify and select appropriate motors, drivers, sensors, and control components.
• Support PLC-based automation and equipment development.
• Prepare, maintain, and manage engineering specifications.
• Purchase and design equipment that meets safety and environmental requirements.
• Assist technicians and engineers in resolving unusual or complex technical problems.
• Perform process and product validation activities.
• Support equipment qualification and related documentation.
• Supervise, coordinate, and technically review the work of a limited group of technicians when required.
• Communicate business-related issues, risks, and opportunities to management.
• Perform additional engineering duties as assigned.

Soft Skills

• Excellent interpersonal and communication skills.
• Strong organizational and planning abilities.
• Strong project management skills.
• Ability to work independently with limited supervision.
• Strong troubleshooting and problem-solving capabilities.
• Ability to collaborate with engineers, technicians, and cross-functional teams.
• Ability to communicate technical issues and recommendations effectively.
• Strong documentation and knowledge-sharing skills.

Software / Computer Skills

• SolidWorks
• CAD software
• Microsoft Project
• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Email and web browsers
• General Windows-based computer applications

Ideal Candidate Profile

• 6–8 years of relevant engineering experience.
• Strong background in electro-mechanical design and NPD/NPI.
• Hands-on experience with SolidWorks, CAD, and GD&T.
• Knowledge of PLCs, stepper motors, drivers, and sensors.
• Experience with automation, robotics, or precision equipment.
• Understanding of GMP and medical device regulations.
• Familiarity with ISO 13485, MDD, and MDR.
• Experience with product/process validation.
• Strong communication, planning, and project management skills.