Nudge (nudge.com)
Quality Systems Engineer
San Francisco
Sponsorship not specifiedDetected 167 days ago
GCPSystems EngineeringElectrical EngineeringClinical TrialsFDA RegulatoryMedical DevicesResearchWritingGxP
About the role
- As a quality systems engineer at Nudge, you will:
- 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
- We are looking for quality systems engineers with at least 2 years of industry experience.
Responsibilities
- 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.
- 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
Requirements
- 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
Skills
- Experience conducting risk management activities using tools such as failure mode and effects analysis (FMEA)
- Strong technical writing skills
Benefits
- 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.
Company info
- At Nudge, our mission is to develop the best technology for interfacing with the brain to improve people's lives.
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