Principal Manufacturing Mechanical Engineer

The role

The Principal Manufacturing Engineer leads cross-functional collaboration to elevate tooling and component quality and deliver cost reduction. This role involves mentoring junior engineers, leading improvement initiatives, and contributing to manufacturing strategy for a total artificial heart.

What you will do

• Champion Lean and Six Sigma methodologies to drive waste reduction
• Evaluate and implement automation and advanced manufacturing techniques
• Lead the design, procurement, and validation of equipment, tools, and fixtures
• Own process validation execution including IQ, OQ, PQ, and PPQ
• Lead NC/CAPA investigations and root cause analysis
• Manage complex, cross-functional manufacturing engineering projects
• Define and enforce manufacturing engineering standards and DFM guidelines
• Shape manufacturing strategy and roadmap development
• Serve as the senior manufacturing engineering voice in cross-functional collaboration
• Establish and maintain manufacturing documentation frameworks

Required qualifications

• BS in Mechanical, Electrical, Biomedical, or Manufacturing Engineering
• 8+ years of engineering experience with advanced skills in process development, Manufacturing Engineering, and industrialization
• Deep expertise in process characterization, pFMEAs, MVP, IQ/OQ/PQ/PPQ, and TMVs
• Comprehensive knowledge of medical device quality regulations including ISO 13485 and FDA quality system regulations

Nice to have

• MS desirable (or equivalent experience)
• medical device or highly regulated industry experience strongly preferred
• Six Sigma Black Belt strongly preferred
• formal project management training or certification (e.g., PMP) is an advantage
• formal or informal people leadership experience is highly regarded

Benefits

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off

Before you apply

• Relocation benefits are not available for this posting

About the company

BiVACOR is developing a total artificial heart technology. The company is an equal opportunity employer.