Sr Process Engineer

Validation & Regulatory Compliance

Lead and execute validation activities in compliance with FDA regulations, Quality System requirements, and company procedures.

Develop, execute, and approve validation protocols and reports including: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Computer System Validation (CSV),

Ensure manufacturing processes, equipment, and systems remain in a validated state.

Support internal and external audits and regulatory inspections.

Problem Solving & Root Cause Analysis

Serve as the technical lead for manufacturing floor problem-solving activities.

Facilitate cross-functional teams to investigate and resolve process, equipment, quality, and productivity issues.

Utilize structured problem-solving methodologies including DMAIC, Six Sigma, Root Cause Analysis (RCA), Fishbone Diagrams, and 5-Why techniques.

Support customer complaint investigations and corrective action implementation.

Capacity Planning & Capital Projects

Evaluate manufacturing capacity requirements based on production forecasts provided by Materials, Supply Chain, and Finance teams.

Develop and execute projects to increase manufacturing capacity and operational efficiency.

Prepare capital expenditure requests, spending budgets, and financial justifications.

Create and submit capital authorization packages, including CB2 requests, for equipment and process improvements.

Manage equipment acquisition, installation, qualification, and startup activities.

Equipment Reliability & Maintenance Support

Partner with Maintenance to develop and improve preventive maintenance programs.

Lead equipment performance improvement initiatives to enhance reliability and uptime.

Support spare parts management activities to ensure critical equipment availability.

Participate in equipment troubleshooting and failure analysis.

Safety, Compliance & Environmental Responsibilities

Promote a culture of safety, compliance, and continuous improvement.

Ensure manufacturing processes comply with EHS standards and regulatory requirements.

Identify and implement opportunities to improve workplace safety and ergonomics.

Ensure proper Personal Protective Equipment (PPE) requirements are established and followed for all process steps.

Participate in risk assessments and hazard mitigation activities.

Minimum Requirement:

Bachelors degree in Engineering, required.

3 years medical device manufacturing, preferred.