Senior Quality Engineer

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

Senior Quality Engineer | Medical-Devices | Full Time | Los Angeles, CA

I’m supporting an early-stage medical technology company developing a highly advanced, software-led surgical platform.

This is an opportunity to join a small, accomplished team working on technology with the potential to improve how complex procedures are performed and ultimately deliver better outcomes for patients.

Quality is still a lean function, so this position offers considerably more ownership than a conventional Senior Quality Engineer role.

You’ll work closely with the company’s quality leadership while independently supporting engineering teams through product development, verification, validation and future manufacturing readiness.

The number-one requirement is deep, practical experience with medical-device design controls.

We’re particularly interested in candidates who have personally supported or owned:

• Design inputs and outputs
• Design reviews and requirements traceability
• Design History Files
• Risk-management activities
• Verification and validation documentation
• Design changes and configuration control
• Software lifecycle and design-assurance activities
• Cross-functional collaboration with software and product-development teams

Because the product is heavily software-led, candidates must also have meaningful experience with software-containing medical devices, including knowledge of IEC 62304 and software V&V.

The wider system incorporates hardware and firmware, so experience working across the interfaces between software, firmware and physical products would be valuable.

Candidates must come directly from the medical-device industry - ideally surgical devices or another complex, safety-critical medical platform. Previous robotics experience is not required.

Additional exposure to manufacturing, supplier quality, design transfer, CAPA or supply-chain environments would be beneficial, but these are secondary to strong design-control and software-quality experience.

This opportunity will suit someone who:

• Can operate independently within a lean quality organization
• Is comfortable creating structure rather than inheriting everything fully established
• Can constructively challenge engineering teams
• Enjoys combining detailed quality work with wider product-development responsibility
• Wants their work to have a visible influence on both the product and the company

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