Sr. Process Engineer

Key Responsibilities:

Lead process characterization activities using statistical tools such as DOE and process capability analysis

Develop and execute studies to assess and improve process performance

Build and maintain PFMEAs and control plans to address compliance gaps

Analyze data to quantify risk and support decision-making

Drive process improvements to align with FDA expectations and regulatory standards

Collaborate with cross-functional teams including Quality and Manufacturing

Key Requirements:

Strong hands-on experience with DOE, process capability, and statistical analysis

Proven experience in process characterization and validation

Experience developing PFMEAs and control plans

Background working in FDA-regulated environments (medical device, pharma, etc.)

Ability to execute studies, interpret data, and drive compliance-focused improvements

Strong communication and documentation skills