Senior Design Assurance Engineer

3 weeks ago

Fremont, California, United States Neuralink Full time

Job Summary:

We are seeking a highly skilled Design Assurance Engineer to join our team at Neuralink. As a key member of our engineering organization, you will be responsible for ensuring that our software meets the highest standards of quality and regulatory compliance.

Main Responsibilities:

  • Develop and execute design control activities to ensure compliance with customer requirements, risk management, quality, and design control standards.
  • Facilitate the successful transfer of designs to manufacturing, ensuring that software components meet medical device regulatory standards.
  • Collaborate with cross-functional teams to develop, apply, revise, and maintain quality and regulatory standards for designing and processing materials and products into partially or finished medical device products, including software components.
  • Implement methods to inspect, test, and evaluate the precision and accuracy of software and/or production equipment.
  • Diagnose and resolve manufacturing and quality system issues related to software components in medical devices.
  • Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new software processes.
  • Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices, Post Market Surveillance plans, and other related documents.

Requirements:

  • Bachelor's Degree in science or engineering, or equivalent experience and ability.
  • Experience with medical device best practices and regulatory requirements for FDA and/or international bodies, specifically concerning SaMD and SiMD.
  • Strong understanding of engineering first principles as they apply to software development.
  • Experience with SaMD/SiMD quality systems, risk management, and compliance.
  • Excellent verbal and written communication.
  • Relentless attention to quality.
  • Experience building processes that are scalable.

Preferred Qualifications:

  • 2+ years of experience with rigorous design control processes in the medical device industry, particularly related to software development.
  • 1+ years of experience working in risk management, with a focus on software-related risks in medical devices.

What We Offer:

  • An opportunity to change the world and work with some of the smartest and most talented experts from different fields.
  • Growth potential; we rapidly advance team members who have an outsized impact.
  • Excellent medical, dental, and vision insurance through a PPO plan.
  • Paid holidays.
  • Commuter benefits.
  • Meals provided.
  • Equity + 401(k) plan.
  • Parental leave.
  • Flexible time off.

Neuralink is an equal opportunity employer:

We provide equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.

Reasonable Accommodations:

If you need a reasonable accommodation at any point in the interview process, please let us know. We will work with you to ensure that you have a fair and equal opportunity to participate in the process.

  • Senior Mechanical Design Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Senior Mechanical Design EngineerWe are seeking a highly skilled Senior Mechanical Design Engineer to join our team at Info Way Solutions. As a Senior Mechanical Design Engineer, you will be responsible for designing, developing, and releasing Hyon Motor's Fuel Cell Technologies and Fuel Cell Systems.The ideal candidate will have a strong...

  • Senior Electrical Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Senior Electrical Engineer - Design and DevelopmentWe are seeking a highly skilled Senior Electrical Engineer to join our team in Andover, MA. As a Senior Electrical Engineer, you will be responsible for designing, developing, and commercializing new wearable diabetes care products.### Key Responsibilities* Design and develop electrical circuits,...

  • Senior Mechanical Design Engineer

    1 month ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Senior Mechanical Design EngineerWe are seeking a highly skilled Senior Mechanical Design Engineer to join our team at Info Way Solutions, LLC. As a key member of our engineering team, you will be responsible for designing and developing innovative mechanical systems for our fuel cell technologies.Responsibilities:Design and develop 3D CAD models...

  • Senior Quality Assurance Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Role:As a Senior Quality Assurance Engineer at Info Way Solutions, you will be responsible for ensuring the quality of our software products.Key Responsibilities:Develop and execute test plans, test cases, and test scripts to identify and report defectsCollaborate with cross-functional teams to develop and implement testing strategiesAnalyze and report...

  • Senior Mechanical Design Engineer

    1 month ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Senior Mechanical EngineerWe are seeking a highly skilled Senior Mechanical Engineer to join our team at Info Way Solutions LLC. The successful candidate will be responsible for designing and developing mechanical systems and components using CATIA V5 and other CAD software.Key Responsibilities:Design and develop 3D CAD models and 2D detailed...

  • Senior Mechanical Design Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    We are seeking a highly skilled Senior Mechanical Design Engineer to join our team at Info Way Solutions. The ideal candidate will have a strong background in mechanical design, with expertise in 3D CAD design and modeling, including 2D detailed drawings, and 3D CAD modeling and design with CATIA V5.The successful candidate will be responsible for designing...

  • Senior Electrical Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Senior Electrical Engineer - Design and DevelopmentWe are seeking a highly skilled Senior Electrical Engineer to join our team at Info Way Solutions. As a Senior Electrical Engineer, you will be responsible for designing, developing, and commercializing new wearable diabetes care products.**Key Responsibilities:*** Design and develop electrical...

  • Senior Manager of Manufacturing Engineering and Quality Assurance

    4 weeks ago

    Fremont, California, United States Siemens Digital Industries Software Full time

    Job Summary:Siemens Digital Industries Software is seeking a highly experienced Senior Manager of Manufacturing Engineering and Quality Assurance to lead our team in delivering high-quality products and services to our customers. As a key member of our organization, you will be responsible for managing and leading a team of quality and manufacturing...

  • Senior Mechanical Design Engineer

    4 weeks ago

    Fremont, California, United States SoloPoint Solutions, Inc. Full time

    Job Summary:SoloPoint Solutions, Inc. is seeking a highly skilled Mechanical Engineer to join our team. As a key member of our design team, you will be responsible for creating and drafting mechanical/electrical/process/controls drawings for various projects.Responsibilities:Create and draft mechanical/electrical/process/controls drawings for various types...

  • Senior Memory IC Design Engineer

    4 weeks ago

    Fremont, California, United States TetraMem INC Full time

    TetraMem is a fast-growing well-funded startup company working on the next generation of computing platforms with unique ReRAM-based in-memory computing technologies.We are seeking a highly skilled Senior Memory IC Design Engineer to join our team.The ideal candidate will have a strong background in CMOS memory design and experience with leading...

  • Senior Mechanical Design Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job SummaryWe are seeking a highly skilled Senior Mechanical Design Engineer to join our team at Info Way Solutions LLC. The successful candidate will be responsible for creating comprehensive 3D CAD designs and 2D detailed drawings using CATIA V5. Key Responsibilities Utilize CATIA V5 to model a diverse range of geometries, from structural brackets to...

  • Senior ASIC RTL Design Engineer

    4 weeks ago

    Fremont, California, United States TetraMem - Accelerate The World Full time

    Revolutionize Computing with TetraMemTetraMem is a pioneering startup company that's changing the game with its innovative ReRAM-based in-memory computing technologies. We're seeking a talented Senior ASIC RTL Design Engineer to join our world-class IC design team and help shape the future of computing.As a key member of our team, you'll be responsible for...

  • Senior Manager of Manufacturing Engineering

    4 weeks ago

    Fremont, California, United States Siemens Industry Software Inc. Full time

    Job Title: Senior Manager of Manufacturing EngineeringJob Summary:Siemens Industry Software Inc. is seeking a Senior Manager of Manufacturing Engineering to lead our manufacturing engineering team. The successful candidate will be responsible for managing and leading a team carrying out quality assurance engineering and manufacturing engineering initiatives,...

  • Electronics Design Engineer Position

    4 weeks ago

    Fremont, California, United States Elma Electronic Full time

    We are seeking an experienced Electronics Design Engineer to join our team at Elma Electronic Inc. in Fremont, CA. The successful candidate will be responsible for designing and developing complex electrical and electronic circuits for our electro-mechanical systems and enclosures.The ideal candidate will have a strong background in power and power supply...

  • Senior Principal Optical Transceiver Design Engineer

    3 weeks ago

    Fremont, California, United States Coherent Full time

    Job DescriptionCoherent is seeking a highly skilled Senior Principal Optical Transceiver Design Engineer to lead the design and development of our optical transceivers. As a key member of our engineering team, you will be responsible for designing and developing high-performance optical transceivers that meet the needs of our customers.Key...

  • Senior Electrical Engineer

    3 weeks ago

    Fremont, California, United States AOSense Full time

    Job SummaryAOSense is seeking a highly skilled Senior Electrical Engineer to design and implement control systems for fieldable atom optic (AO) gyroscopes, accelerometers, absolute gravimeters, gravity gradiometers, inertial measurement units (IMUs), magnetometers, and atomic frequency standards.The ideal candidate will have expertise in low-noise analog,...

  • Senior Optical Transceiver Design Engineer

    4 weeks ago

    Fremont, California, United States Coherent Full time

    Job SummaryWe are seeking a highly skilled Senior Optical Transceiver Design Engineer to join our team at Coherent. As a key member of our engineering team, you will be responsible for the design and testing of PAM4 optical transceivers for datacenter, AI/ML, and HPC applications.Key ResponsibilitiesDesign and develop PAM4 optical transceivers for high-speed...

  • Senior Frontend Engineer

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Senior Frontend EngineerJob Description:We are seeking a skilled Senior Frontend Engineer to contribute to the development of our web applications. As a Senior Frontend Engineer, you will be responsible for designing and implementing front-end solutions using the Angular framework. The ideal candidate should have a strong understanding of web...

  • Senior Hardware Design Verification and Validation Engineer

    3 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Job Summary:Info Way Solutions is seeking a highly skilled Senior Hardware Design Verification and Validation Engineer to join our team. As a key member of our engineering team, you will be responsible for ensuring the safety and effectiveness of our medical devices through rigorous verification and validation processes.Key Responsibilities:Develop and...

  • Senior Electrical Design Engineer

    4 weeks ago

    Fremont, California, United States PHIHONG USA Full time

    Job OverviewWe are seeking a highly skilled Electrical Design Engineer with a strong foundation in electrical and power supply concepts, combined with hands-on experience in designing and optimizing power supply systems.The ideal candidate will have a solid theoretical background in electrical engineering, specifically in power supply design, and experience...