Senior Product Engineer
Core
Lead engineering activities for new and existing medical devices, managing design control, risk assessments, and regulatory compliance while investigating product failures.
Role type
Senior IC product engineer (medical devices)
Builds
Medical devices and product improvements
Domain
Medical devices / Healthcare
Deliverable
product features
Required skills
Mechanical/Electrical/Biomedical engineering, design control, risk assessment, root cause analysis, statistical analysis, engineering testing, regulatory documentation, cross-functional collaboration
Preferred skills
FDA regulations, design controls, risk management, SolidWorks, process improvement
Technologies
SolidWorks
Responsibilities
Lead engineering activities for product improvements and design changes; Manage design control activities and regulatory documentation; Investigate product failures and implement corrective actions; Support customer complaint investigations; Plan and execute engineering research and validation activities; Collaborate with R&D, Quality, Regulatory, and Manufacturing teams; Apply statistical analysis and testing methods; Drive continuous improvement initiatives
Seniority
Senior, hands-on IC