Quality Systems Engineer

Healy World; San Francisco (CA); Hybrid; USD 110,000 - 165,000; Full time

Job summary

Nudge is seeking a Quality Systems Engineer to ensure our devices meet safety and regulatory requirements. You will lead quality discussions, drive changes across design controls, investigations, and clinical trials involvement where needed.

Ideal candidates have at least 2 years of relevant experience, strong technical writing, and familiarity with GCP, ISO standards, and FMEA-driven risk management. Join a mission-driven team shaping brain interface technology.

Qualifications

• Minimum 2 years of quality systems engineering experience.
• Experience with design controls, validation, and risk management.
• Familiarity with GCP, FDA QMSR, ISO 13485, and ISO 14971.
• Experience conducting risk management using FMEA.
• Strong technical writing and communication abilities.

Responsibilities

• Ensure all product designs and processes meet safety and regulatory requirements.
• Lead quality discussions and drive necessary process changes across design controls and trials.
• Manage multiple tasks and drive change orders to completion.
• Lead CAPA investigations and implement mitigations.
• Collaborate with interdisciplinary teams to uphold high quality standards.

Skills

Design controls

Product/process validation

Risk management

Technical writing

Integrity & judgement

Education

Engineering or scientific degree

Tools

FMEA

Job description

About Nudge

At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives. We're starting with an approach that we believe can help the most people the fastest, and also allow us to learn as much about the brain as possible: developing a non-invasive, ultrasound-based device that can stimulate and image the brain at high resolution and depth. This is a vertically integrated effort building cutting-edge hardware, software, and research capabilities to create products that can benefit millions — and eventually billions — of people.

To succeed, we need to assemble world‑class teams across everything we do. We hire people who are exceptional at their craft, believe hard things are worth doing, and execute relentlessly — people who expect the highest levels of both rigor and integrity from each other.

About the role

As a quality systems engineer at Nudge, you will:

• Ensure that new and existing product designs and processes meet all internal and regulatory requirements with respect to safety and performance
• Partner in new product development by leading quality critical discussions, influencing key decisions, and driving necessary process changes across design controls, investigational studies, and clinical trials
• Effectively manage multiple tasks and drive execution of change orders
• Initiate and/or support corrective action and preventive action (CAPAs) and non‑conformances, leading investigations and implementing mitigations
• Represent and cultivate a culture of quality by working with interdisciplinary teams to set expectations, identify gaps, and meet a high internal bar for rigor

About you

We are looking for quality systems engineers with at least 2 years of industry experience. Regardless of career level, you should have:

• Experience with design controls, product/process validation, and risk management
• A degree in an engineering or scientific discipline (e.g., biomedical engineering, electrical engineering, neuroscience) or equivalent hands‑on experience
• Familiarity with Good Clinical Practice (GCP) and human factors
• Familiarity with the FDA QMSR, ISO 13485, and ISO 14971
• Experience conducting risk management activities using tools such as failure mode and effects analysis (FMEA)
• Strong technical writing skills
• High integrity and strong professional judgement