Senior Engineer
Talent Software Services
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
- 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
- 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.
- 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.
- 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
- 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.
- 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
- Minimum requirement: 5 years.
- Preferred experience: 5-8 years.
- If No: Reject the candidate.
- If No: Reject the candidate.
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