Senior Quality Engineer - Medical Devices, Software-Driven

Stelvio Inc.; Los Angeles (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Stelvio Inc. in Los Angeles, CA is seeking a Senior Quality Engineer for a software-led medical-device platform. You’ll lead design-controls activities, collaborate with software, hardware and manufacturing teams, and drive verification, validation and readiness for manufacturing.

This lean quality role emphasizes ownership, structured processes, and proactive quality leadership to influence the product and company trajectory, with direct impact on patient outcomes.

Qualifications

• Extensive medical-device design-controls experience with IEC 62304.
• Proven capability in design inputs/outputs, design reviews and traceability.
• Strong DHF experience and documentation discipline.
• Software-containing medical-device quality and V&V expertise.
• Ability to collaborate across software, hardware and manufacturing teams.
• Direct experience in a medical-device environment; surgical devices a plus.

Responsibilities

• Support engineering teams through product development, verification, validation and manufacturing readiness.
• Lead lean quality activities and build structure within a small team.
• Ensure design-controls compliance and robust software quality across interfaces.
• Collaborate with software, firmware and hardware teams to manage risk and changes.

Skills

Design controls (IEC 62304)

Software quality

Risk management

Design inputs/outputs

Design reviews & traceability

DHF & documentation

V&V for software devices

Cross-functional collaboration

Job description

Stelvio Inc. in Los Angeles, CA is seeking a Senior Quality Engineer for a software-led medical-device platform. You’ll lead design-controls activities, collaborate with software, hardware and manufacturing teams, and drive verification, validation and readiness for manufacturing.

This lean quality role emphasizes ownership, structured processes, and proactive quality leadership to influence the product and company trajectory, with direct impact on patient outcomes.