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.