Principal Manufacturing EngineerRussell Solutions Group • Fremont, CA, US
Principal Manufacturing Engineer
Russell Solutions Group • Fremont, CA, US
28 days ago
Job type
- Full-time
Job descriptionOur 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 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
Job Description
Job Description
Qualifications
- 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
Responsibilities
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Manufacturing Engineer • Fremont, CA, US