Sr. Manufacturing Quality Engineer

Senior Manufacturing Quality Engineer (no sponsorship available)

Location: South Bay Area

Salary Range

$135,000 – $155,000, plus up to 10% annual bonus

Schedule: On-site 4 days/week, remote 1 day/week

About the Role

We're hiring a Senior Manufacturing Quality Engineer to help modernize and scale our test method validation (TMV) capabilities for catheter-based medical devices. This role sits at the center of our manufacturing quality efforts, working daily and closely with the Manufacturing team to improve test methods, resolve defects, and drive manufacturing yield.

The immediate focus is transitioning a manual measurement setup to an automated one (feeding directly into SPC processes), and executing TMV as that system comes online.

This is not a supplier quality role and not a primary NCR/CAPA ownership role — the emphasis is on test methods, measurement systems, and manufacturing support.

Key Responsibilities

• Lead test method validation (TMV) efforts, with hands-on use of MicroVu measurement systems
• Support the transition to an automated/motorized measurement table — setting up equipment so units can be measured and data automatically fed into a shared system
• Design basic inspection tooling and fixtures (simple, shop-machinable — not complex assemblies) using SolidWorks
• Develop and maintain statistical process control (SPC) practices as the new system comes online
• Work daily with the Manufacturing team to troubleshoot production issues and improve yields
• Provide secondary/supporting involvement in audits (not primary audit owner)
• Contribute to root cause analysis and documentation for manufacturing defects
• Maintain compliance with quality system regulations (QSR, ISO 13485, ISO 14971, FDA/EU MDR)
• Author/maintain documentation for test methods and inspection procedures

Qualifications

• BS in Mechanical Engineering preferred (Biomedical Engineering also considered)
• 4-7 years of related medical device experience
• Strong hands-on TMV experience; MicroVu experience is a must
• Proficiency in SolidWorks (3D modeling) for fixture design
• Experience with a quality management system (e.g., MasterControl or equivalent — exact platform not required)
• CMO (contract manufacturing) experience is a plus
• Strong written communication for technical justifications and reports
• Comfortable working independently and cross-functionally with manufacturing teams

Benefits

• Medical, dental, and vision insurance (fully covered)
• 401(k) with company match
• Paid time off starting at 3 weeks/year
• Employee stock options
• Life, AD&D, and long-term disability insurance
• Education/tuition assistance
• Voluntary commuter and pet insurance benefits
• Regular team lunches and social events