Q'Apel Medical · 1 day ago
Sr. Manufacturing Engineer (Medical Devices)
Fremont, Fremont, CA, US
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $175K/yr
10+ years expQ’Apel Medical is redefining neurovascular access with breakthrough technology. They are seeking a Senior Manufacturing Engineer to drive the industrialization of next-generation neurovascular devices, ensuring scalable and cost-effective production while maintaining world-class quality standards.
Health CareMedicalMedical Device
Responsibilities
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
Qualification
Required
Bachelor's degree in engineering or related field (or equivalent technical experience)
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
Skilled in statistical process control, DOE, and Six Sigma tools
Track record of leading cross-functional projects from concept through commercialization
Strong verbal/written communicator with the ability to influence across all levels
Agile problem-solver who thrives under pressure in dynamic environments
Willingness to travel periodically to suppliers, partners, and contract manufacturers
Preferred
Master's degree in engineering or related field
Skilled in CAD software (SolidWorks preferred)
Benefits
Equity
Benefits
Company
Q'Apel Medical
Q'Apel Medical designs access device technology for neurovascular interventions and unmet clinical needs.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$69.03M2024-05-09Series Unknown· $17.13M
2022-04-04Series Unknown· $29.9M
2021-02-11Series C· $22M
Leadership Team
R. King Nelson
CEO & Director
Jeff Krolik
Chief Technology Officer
Recent News
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