Principal Manufacturing Engineer

Full-time - Senior

Irvine, CA

Miscellaneous Manufacturing

About the position

The Principal Manufacturing Engineer at Beta Bionics will serve as a key leader in the design, development, and optimization of advanced manufacturing processes, ensuring efficiency, regulatory compliance, and innovation in medical device production. This role will be instrumental in strategic planning, cross-functional collaboration, and driving continuous improvement initiatives aligned with ISO 13485 standards. The Principal Manufacturing Engineer will act as a mentor and technical authority, influencing best practices across the organization while ensuring product quality, cost-effectiveness, and scalability.

Responsibilities

• Lead the development, validation, and implementation of innovative manufacturing processes for medical devices in compliance with ISO 13485 and FDA regulations.
• Develop long-term manufacturing strategies to improve quality, efficiency, and scalability, aligning with business objectives.
• Identify opportunities for automation and digital manufacturing to enhance production capabilities.
• Establish and enforce compliance with Good Manufacturing Practices (GMP), ISO 13485 standards, and FDA regulations.
• Oversee risk management and ensure robust design transfer methodologies for new product introductions.
• Develop and maintain high-level manufacturing documentation, including standard operating procedures (SOPs) and work instructions.
• Evaluate and approve suppliers based on quality standards, capacity, and manufacturing capabilities.
• Collaborate with suppliers to qualify materials and processes, ensuring they meet stringent regulatory and company standards.
• Lead supplier development initiatives to ensure long-term reliability and cost-effectiveness.
• Act as a senior technical resource, providing guidance and strategic direction across engineering, R&D, quality, and operations teams.
• Establish and foster strong relationships with internal and external stakeholders, ensuring seamless integration of new processes into manufacturing.
• Serve as a key liaison for executive leadership, providing insights on manufacturing capabilities, constraints, and opportunities.
• Lead and manage high-impact engineering projects, ensuring successful execution within budget and timeline constraints.
• Utilize Lean Six Sigma methodologies to drive continuous improvement, cost reduction, and waste elimination across manufacturing operations.
• Champion a culture of technical excellence, fostering creativity and innovation in process development.
• Provide leadership and mentorship to junior and senior manufacturing engineers, developing talent and fostering career growth.
• Conduct training programs for manufacturing teams, ensuring adherence to best practices and regulatory compliance.

Requirements

• Bachelor's Degree in Mechanical, Manufacturing, or Industrial Engineering (Master's preferred).
• 10+ years of experience in a medical device manufacturing environment, or other regulated industry.
• Proven experience leading complex manufacturing projects and cross-functional teams.
• Deep expertise in Lean manufacturing, Six Sigma, and process validation.
• Proficiency in CAD, parametric modeling, and manufacturing simulation tools.
• Strong analytical, problem-solving, and decision-making skills.

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule