Design Engineer (Medical Devices)

Job Overview:

• We are looking for an enthusiastic Design Engineer with 5 to 8 years of experience in the development of medical device products.
• The successful applicant will possess extensive knowledge in Mechanical Product Design Development, Design Controls, DFMEA, Risk Management, and Design Documentation.
• This position requires leading new product development initiatives while ensuring adherence to medical device regulations and quality standards.

Primary Duties:

• Oversee mechanical design and development projects for medical device products.
• Implement Medical Device Design Control processes throughout the entire product development lifecycle.
• Generate innovative concepts, detailed designs, and engineering solutions for both new and existing products.
• Develop and maintain design documentation such as design inputs, design outputs, verification, validation, and design reviews.
• Conduct DFMEA (Design Failure Mode and Effects Analysis) and engage in risk assessment activities.
• Execute risk management activities in compliance with relevant regulatory requirements.
• Create and maintain technical drawings, specifications, BOMs, and engineering documentation.
• Work collaboratively with cross-functional teams including R&D, Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
• Assist in design verification and validation testing activities.
• Promote design enhancements, cost reduction, and product reliability initiatives.
• Ensure adherence to industry standards, quality systems, and regulatory requirements.

Technical Qualifications:

• Proven expertise in Mechanical Product Design Development.
• Practical experience with Medical Device Design Controls.
• Proficient in DFMEA and Risk Management techniques.
• Experience in design documentation and engineering change management.
• Understanding of product lifecycle management and design transfer processes.
• Comprehensive knowledge of manufacturing processes and engineering principles.
• Exceptional problem-solving, analytical, and communication abilities.

Additional Qualifications:

• Previous experience in the Medical Devices sector.
• Familiarity with ISO 13485, ISO 14971, and FDA design control requirements.
• Exposure to design verification and validation processes.
• Proficient in CAD tools such as SolidWorks or similar applications.
• Experience in regulated product development environments.

Preferred Skills:

Technology->CAD->AutoCAD, Technology->Embedded Software->Medical Devices