Description

You will lead the closeout of process validations for a pilot manufacturing line focused on subcutaneous glucose sensors.

Responsibilities

• Execute validation test plans and generate formal test reports.
• Prepare IQ/OQ/PQ protocols and coordinate sample builds with full traceability documentation.
• Characterize new process equipment and document experimental results in engineering reports.
• Perform statistical analysis on test data to provide status reports for engineering teams.
• Create and revise assembly procedures and controlled drawings for components and assemblies.

Required Skills

• BS in Biomedical, Mechanical, or Chemical Engineering.
• 5+ years of experience in validation or process engineering.
• Hands-on experience working in clean room or wet lab environments.
• Proven experience developing Design of Experiments (DOEs).
• Proficiency in Minitab statistical analysis software.
• Experience analyzing large datasets and performing relevant statistical analysis.
• Strong technical writing skills for protocols, procedures, and engineering reports.
• Ability to coordinate with outside vendors and provide technical line support.

Preferred Skills

• Experience in the medical device or healthcare industry.

Key Skills

Education

Any Graduate