Principal Manufacturing Engineer

Job Description

Job DescriptionQualifications

• 10+ years of experience in medical device manufacturing engineering, ideally in neurovascular or catheter-based technologies
• Expertise in design controls, validation, process development, and documentation within a regulated environment
• Deep understanding of FDA regulations, ISO 13485, MDD/MDR, and global QMS standards
• Strong verbal/written communicator with the ability to influence across all levels
• Agile problem-solver who thrives under pressure in dynamic environments

Benefits

• Our salary ranges are calculated by role and level
• The base salary range for this full-time position is between $130,000 to $150,000 + equity + benefits

Responsibilities

• You'll be a key technical leader, working at the intersection of R&D, quality, and production to ensure our breakthrough designs are scalable, cost-effective, and flawlessly executed
• You'll bring products from concept to commercial scale, helping accelerate time-to-market while upholding world-class quality standards
• Lead design-for-manufacturability (DFM) efforts for new neurovascular/vascular products
• Spearhead design transfer activities, ensuring seamless handoff from R&D to production
• Develop and validate custom equipment, fixtures, and manufacturing processes that scale
• Partner with suppliers and contract manufacturers to source critical components and capabilities
• Lead protocol development and execution for design verification, validation, and process qualification
• Troubleshoot complex manufacturing issues and implement data-driven solutions using Six Sigma and root cause analysis tools
• Author and maintain documentation that meets FDA, ISO 13485, and global regulatory requirements
• Drive CAPA investigations, NC resolution, and continuous process improvement in production
• Act as a cross-functional leader, collaborating with Quality, R&D, Operations, and Regulatory to launch high-impact medical products
• Track record of leading cross-functional projects from concept through commercialization
• Willingness to travel periodically to suppliers, partners, and contract manufacturers