Design Engineer (Medical Devices)

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

Technical Requirements:

• Strong experience in Mechanical Product Design Development
• Hands on experience with Medical Device Design Controls
• Expertise in DFMEA and Risk Management methodologies
• Experience in design documentation and engineering change management
• Knowledge of product lifecycle management and design transfer processes
• Strong understanding of manufacturing processes and engineering fundamentals
• Excellent problem solving analytical and communication skills

Additional Responsibilities:

• Prior experience in the Medical Devices Industry
• Familiarity with ISO 13485 ISO 14971 and FDA design control requirements
• Exposure to design verification and validation processes
• Knowledge of CAD tools such as SolidWorks or equivalent
• Experience working in regulated product development environments

Preferred Skills:

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