Senior Engineer

Job Details

• Job Title: Senior Engineer

• Location: Irvine, California

• Duration: 6 months

• Experience Required: 6-8 years

• Essential Skills:

• Medical Device Industry and Regulations

• New Product Development (NPD) Methodology and Management

• Skill Category: EIS - Medical Device & Regulations / NPD Methodology and Management

Must-Have Technical/Functional Skills

• Knowledge and experience in Product Development and New Product Development (NPD).

• Ability to design and develop electromechanical systems and components.

• Experience integrating mechanical and electrical components into complete systems.

• Knowledge of stepper motors, motor drivers, sensors, and PLC programming for equipment design.

• Experience performing mechanical, electromechanical, and developmental design activities with limited supervision.

• Experience in industrial automation, robotics, or precision instruments is preferred.

• Strong experience with SolidWorks and CAD software.

• Knowledge of Geometric Dimensioning and Tolerancing (GD&T).

• Knowledge of Good Manufacturing Practices (GMP) and manufacturing documentation, preferably in the medical device industry.

• Knowledge of ISO 13485 and medical device regulatory standards, including MDD and MDR.

• Knowledge of Statistical Analysis and Design of Experiments (DOE) is preferred.

• Proficiency in computer applications and engineering software.

• Strong interpersonal, communication, organizational, planning, and project management skills.

• Proficiency in Microsoft Office applications, including:

• Microsoft Word

• Microsoft Excel

• Microsoft PowerPoint

• Microsoft Project

• Email and web browsers

• Project planning and spreadsheet software

Roles and Responsibilities

• Identify, design, and develop equipment required for new product development.
• Study existing manufacturing processes and implement improvements to support new products.
• Implement automation solutions in manufacturing processes and tooling.
• Prepare, manage, and maintain engineering specifications.
• Assist technicians and engineers in troubleshooting and resolving unusual technical problems.
• Purchase and design equipment that meets applicable safety and environmental requirements.
• Perform process and product validation activities.
• Supervise, coordinate, and technically review the work of a limited group of technicians.
• Communicate business-related issues, project updates, and improvement opportunities to the next level of management.
• Ensure engineering activities comply with applicable federal, state, and local regulations, corporate procedures, and guidelines.
• Support mechanical and electromechanical design activities under limited supervision.
• Contribute to continuous process improvement and automation initiatives.
• Perform other duties and responsibilities as assigned.

Generic Managerial Skills

• No specific generic managerial skills are listed.
• Strong communication and interpersonal skills are expected.
• Ability to collaborate effectively with engineers, technicians, and cross-functional teams.
• Strong organizational, planning, and project management capabilities.

Essential Skills

• Electromechanical Engineering
• New Product Development (NPD)
• Mechanical Design
• Product Development Processes
• Industrial Automation
• Mechatronics
• Fixture Design
• SolidWorks
• CAD Software
• Geometric Dimensioning and Tolerancing (GD&T)
• PLC Programming
• Stepper Motors, Motor Drivers, and Sensors
• Process and Product Validation
• Design of Experiments (DOE)
• Medical Device Regulations
• ISO 13485, MDD, MDR, and GMP

Experience Requirements

• Overall experience: 6-8 years.
• Medical device industry experience: Minimum 5 years; 5-8 years preferred.
• NPD experience: Knowledge and experience in New Product Development are required.
• Automation experience: Knowledge of automation is mandatory for screening.
• Design experience: Hands-on experience in mechanical and electromechanical design, CAD, and SolidWorks.
• Regulatory knowledge: Familiarity with medical device quality systems and regulatory requirements.

Key Resume Search Keywords

• Electromechanical Engineering
• Product Development Processes
• Fixture Design
• Mechanical Design
• CAD
• SolidWorks
• Design of Experiments (DOE)
• New Product Development (NPD)
• Mechatronics
• Industrial Automation
• PLC Programming
• Medical Devices
• GD&T
• Process Validation

Pre-Screening Questionnaire

• 1. Medical Device Industry Experience: How many years of experience does the candidate have in the medical device domain?
• Minimum requirement: 5 years.
• Preferred experience: 5-8 years.
• 2. NPD and Automation Knowledge: Does the candidate have knowledge and experience in New Product Development (NPD) and automation?
• If No: Reject the candidate.
• 3. Relocation: Is the candidate willing to relocate to Irvine, California?
• If No: Reject the candidate.