Medical Device Design Engineer

Role Overview:

This role involves the design and development of electro-mechanical systems and components, primarily within New Product Development (NPD) engineering for the medical device industry. The engineer will be responsible for system integration, automation implementation, and ensuring compliance with medical device regulatory standards.

Key Responsibilities:

• Design and develop electro-mechanical systems and components.
• Perform system integration of mechanical and electrical parts.
• Identify and utilize stepper motors, drivers, and sensors with PLC programming in design.
• Perform mechanical and electromechanical developmental design duties in New Product Development engineering.
• Identify, design, and develop necessary equipment related to new product development.
• Study existing processes to implement improvements on new products.
• Implement automation in processes and tools.
• Prepare and manage specifications.
• Assist technicians and engineers with unusual problems, and be responsible for purchasing and designing equipment that meets safety and environmental requirements.
• Perform activities of process/product validation.
• Supervise, coordinate, and technically revise the work of a limited group of technicians (under limited supervision).
• Communicate business-related issues or opportunities to the next management level.

Required Skills:

• Strong experience with SolidWorks / CAD software and GD&T.
• Knowledge of good manufacturing practices and documentation, preferably in the medical industry.
• Knowledge of ISO 13485, Medical Device Regulatory Standards, MDD and MDR.
• Knowledge and experience in product development/NPD.
• Experience in identifying and using stepper motors, drivers, sensors using PLC programming in Design.
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills.
• Proficiency with personal computer skills, including Microsoft Project, Windows, word processing, project planning, presentation, e-mail, and spreadsheet software.

Qualifications:

• 6-8 years of experience in a relevant engineering role.
• Demonstrated knowledge of Medical Device & Regulations.
• Experience with New Product Introduction Process (NPI) - Product Engineering.

Preferred Skills:

• Experience with industrial automation, robotics, or precision instruments.
• Knowledge of statistical analysis and design of experiments (DOE).