- 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 recent 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 Solid Works or equivalent
- Experience working in regulated product development environments