Job Description:

We are seeking a highly motivated Design Engineer with 5 to 8 years of experience in Medical Device Product Development
The ideal candidate will have strong expertise in Mechanical Product Design Development Design Controls DFMEA Risk Management and Design Documentation
This role involves driving new product development activities while ensuring compliance with medical device regulations and quality standards

Key Responsibilities:

Lead mechanical design and development activities for medical device products
Apply Medical Device Design Control processes throughout the product development lifecycle
Develop innovative concepts detailed designs and engineering solutions for new and existing products
Create and maintain design documentation including design inputs design outputs verification validation and design reviews
Conduct DFMEA Design Failure Mode and Effects Analysis and participate in risk assessment activities
Perform risk management activities in accordance with applicable regulatory requirements
Generate and maintain technical drawings specifications BOMs and engineering documentation
Collaborate with cross functional teams including R D Quality Regulatory Affairs Manufacturing and Supply Chain
Support design verification and validation testing activities
Drive design improvements cost optimization and product reliability initiatives
Ensure compliance with industry standards quality systems and regulatory requirements

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