Principal Manufacturing Mechanical Engineer

About the Company

BiVACOR is developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world. We are a team united by purpose, working on unprecedented medical technology.

Responsibilities

• Champion Lean and Six Sigma methodologies to drive waste reduction and continuous improvement
• Evaluate and implement automation and advanced manufacturing techniques to improve throughput and cost-effectiveness
• Lead the design, procurement, and validation of equipment, tools, and fixtures
• Own process validation execution (IQ, OQ, PQ, PPQ) in compliance with FDA, ISO 13485, and GMP standards
• Lead NC/CAPA investigations and root cause analysis to implement corrective and preventive actions
• Manage complex, cross-functional manufacturing engineering projects from initiation to completion
• Define and enforce manufacturing engineering standards and design-for-manufacturability (DFM) guidelines
• Shape manufacturing strategy and roadmap development for scale-up and technology transfer
• Establish and maintain manufacturing documentation including BOMs, work instructions, and process flow charts
• Author and review technical documentation for audits and regulatory submissions

Requirements

• BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering (MS desirable)
• 8+ years of engineering experience in process development and industrialization
• Medical device or highly regulated industry experience strongly preferred
• Deep expertise in process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs
• Comprehensive knowledge of ISO 13485 and FDA quality system regulations
• Advanced problem-solving skills; Six Sigma Black Belt strongly preferred
• Experience leading cross-functional projects and mentoring junior engineers

Preferred Qualifications

• Formal project management training or certification (e.g., PMP)
• Formal or informal people leadership experience