Not specified; retention bonus issued after three-...
Fully remote
Bachelor's degree in engineering
6 years medical device experience
Fda qsr and iso environment
This role focuses on executing design validation remediation for legacy product families to meet current regulatory expectations
Job Summary
This role focuses on executing design validation remediation for legacy product families to meet current regulatory expectations.
The position requires strong cross-functional collaboration with Regulatory Affairs and Systems Engineering to ensure thorough, risk-retiring activities.
Employees are expected to work on-site a minimum of 4 days per week to foster creativity and effective problem-solving.
Matching Summary
This role focuses on executing design validation remediation for legacy product families to meet current regulatory expectations.
Salary
Not specified; Retention bonus issued after three-year term
Skills & Requirements
Must-have
Bachelor's Degree in Engineering
6 years medical device experience
FDA QSR and ISO environment
Design validation remediation
Risk documentation maintenance
Nice-to-have
Solidworks CAD proficiency
Minitab statistical software
Six Sigma or Design for Six Sigma training
C/C++ embedded systems knowledge
IEC 60601 standards expertise
Key Requirements
Bachelor's Degree in Electrical, Mechanical, Biomedical, or related field
Minimum 6 years related work experience in regulated FDA/QSR/ISO environment
Proficiency in writing protocols and technical documentation for verification and validation