Mechanical Design Engineer - Medical Devices
Location: Lake Forest, IL
Duration: 1 year
- Bachelor's degree in Mechanical Engineering
- Good Experience in working in Medical devices and knowledge in medical quality process.
- Should have worked in medical new product development projects
- Rich experience in working on disposable medical devices
- Should have worked in ISO 13485 / 21CFR820 (design control processes) compliant environment
- Good knowledge in plastic design, plastic manufacturing process & plastic joining process
- Should be able to own DFMEA for Consumables (IV Administration sets, syringes, etc.) & have a good understanding of risk management activities per ISO 14971 standard
- Should be able to review and analyze On-Market product complaint data and identify the risk controls
- Should have worked in 3D modeling software like Solidworks
- Excellent written and verbal communication is a must.