Talent.com
Senior Design Assurance Quality Engineer

Senior Design Assurance Quality Engineer

Neptune MedicalBurlingame, CA, US
1 day ago
Job type
  • Full-time
Job description

Neptune Medical is a venture backed medical device company based in Silicon Valley. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology. Pathfinder is our first FDA-cleared commercial device incorporating this novel technology. This advanced endoscopy device is being used at a growing list of leading U.S. hospitals and academic medical centers. Now, the team at Neptune is building something truly unique : a fully flexible medical robot that enables doctors to reach deep into human anatomy. Triton Robotic Endoscopy will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

TITLE : Senior Design Assurance Quality Engineer

POSITION SUMMARY :

The Senior Design Assurance Quality Engineer plays a critical role in ensuring medical devices meet safety, effectiveness, regulatory compliance, and business requirements throughout the design and development process. This position involves collaboration with Operations, Project Management, Regulatory, and Research & Development to establish design controls, risk management processes, and quality assurance protocols. The engineer will support product development from concept through commercialization, ensuring compliance with industry standards such as FDA regulations, ISO 13485, IEC 62304 and ISO 14971. They are responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality Management System compliance.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES :

  • Develop and maintain Design History Files (DHF) and ensure compliance with regulatory requirements.
  • Support the creation of technical documentation, including design specifications, verification / validation protocols, and risk management files.
  • Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
  • Lead risk analysis activities such as Hazard Analysis, Design Failure Modes and Effects Analysis (DFMEA) and Process FMEA.
  • Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
  • Plan, execute, and document design verification and validation activities, including software validation.
  • Coordinate with third-party test houses for compliance testing (e.g., EMC, EMI) to meet regulatory standards.
  • Support biocompatibility and sterilization qualifications.
  • Supports product Post Market activities such assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
  • Provide support for internal audits and regulatory inspections.

REQUIRED QUALIFICATIONS :

  • B.S. or M.S. in an Engineering discipline or related field of study.
  • Minimum of 5 years of experience in the medical device industry; Class II or III electro-mechanical medical devices preferred.
  • Hands-on experience with design controls, risk management practices, and regulatory submissions (e.g., FDA QSRs).
  • Proficiency in standards such as ISO 13485, ISO 14971, IEC 60601, IEC62304.
  • Advanced statistical methods knowledge (e.g., DOE, ANOVA) using tools like Minitab.
  • Working knowledge of verification and validation requirements for a regulated product
  • Working knowledge of requirements analysis, including development of testable and measurable specifications
  • Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion / resolution
  • Ability to manage multiple projects simultaneously under tight deadlines.
  • Willingness to work in a startup environment and adapt to changing needs and priorities.
  • Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines.
  • Excellent verbal and written communications skills including presentation of technical content.
  • Eagerness to learn new things.
  • Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

    Our job titles may span more than one career level. The starting base salary for this role is between $140,000 and $175,000 depending on experience. The actual base pay is dependent upon many factors, such as : education, training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

    Neptune Medical provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

    Create a job alert for this search

    Senior Quality Assurance Engineer • Burlingame, CA, US

    Related jobs
    • Promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    VirtualVocationsSan Jose, California, United States
    Full-time
    A company is looking for a Quality Assurance Engineer to maintain software quality and establish best practices.Key Responsibilities Create, execute, and automate test plans for Claims Manager an...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Assurance Manager

    Quality Assurance Manager

    VirtualVocationsConcord, California, United States
    Full-time
    A company is looking for a Manager of Quality Assurance to join their remote development team.Key Responsibilities Lead the Quality Assurance team, enhancing quality assurance processes and tooli...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Quality Automation Engineer

    Senior Quality Automation Engineer

    VirtualVocationsConcord, California, United States
    Full-time
    A company is looking for a Senior Quality Automation Engineer - Firmware.Key Responsibilities Champion automation frameworks and collaborate with engineering teams to design APIs prioritizing aut...Show moreLast updated: 25 days ago
    Senior Design Verification Engineer

    Senior Design Verification Engineer

    quadric, IncBurlingame, CA, US
    Full-time
    Quick Apply
    Quadric has created an innovative general purpose neural processing unit (GPNPU) architecture.Quadric's co-optimized software and hardware is targeted to run neural network (NN) inference workloads...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Software Quality Assurance Engineer

    Senior Software Quality Assurance Engineer

    SynopsysMountain View, CA, United States
    Full-time
    The R&D Verification Engineer joins Ansys Government Initiatives Professional Services team to perform software testing and quality assurance on industry-leading enterprise software solutions that ...Show moreLast updated: 1 day ago
    • Promoted
    Senior Design Assurance Quality Engineer

    Senior Design Assurance Quality Engineer

    Neptune MedicalBurlingame, CA, United States
    Full-time
    Neptune Medical is a venture backed medical device company based in Silicon Valley.We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technolog...Show moreLast updated: 9 days ago
    • Promoted
    Design Quality Partner

    Design Quality Partner

    F. Hoffmann-La Roche AGPleasanton, CA, United States
    Full-time
    Design Quality Partner page is loaded## Design Quality Partnerlocations : Pleasanton : Santa Claratime type : Full timeposted on : Posted Todayjob requisition id : 202509-125279At Roche you ca...Show moreLast updated: 7 days ago
    • Promoted
    Quality Assurance Director (Automation)

    Quality Assurance Director (Automation)

    Critical MassSan Jose, CA, US
    Full-time
    Quality Assurance Director (Automation).Our Quality Assurance practice is integrated across the entire project lifecycle, ensuring the agreed-upon standards and requirements are met in order to del...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Design Assurance Quality Engineer (Burlingame)

    Senior Design Assurance Quality Engineer (Burlingame)

    Neptune MedicalBurlingame, CA, US
    Part-time
    Neptune Medical is a venture backed medical device company based in Silicon Valley.We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization technology...Show moreLast updated: 4 days ago
    • Promoted
    Design Verification Engineer

    Design Verification Engineer

    Mythic, Inc.Palo Alto, CA, United States
    Full-time
    We’re hiring experienced Design Verification Engineers from junior to senior levels to play a key role in developing and verifying the designs that will bring our next-generation AI processors to l...Show moreLast updated: 3 days ago
    • Promoted
    Supplier Quality Assurance Engineer

    Supplier Quality Assurance Engineer

    VirtualVocationsHayward, California, United States
    Full-time
    A company is looking for a Supplier Quality Assurance Engineer (Level 2).Key Responsibilities Achieve total quality performance across multiple sites for strategic suppliers Lead suppliers in de...Show moreLast updated: 2 days ago
    • Promoted
    Quality Assurance Senior Analyst

    Quality Assurance Senior Analyst

    VirtualVocationsOakland, California, United States
    Full-time
    A company is looking for a Quality Assurance Senior Analyst, fully remote.Key Responsibilities Review business requirements and translate them into actionable test cases for manual execution Col...Show moreLast updated: 1 day ago
    • Promoted
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    VirtualVocationsFremont, California, United States
    Full-time
    A company is looking for a Supplier Quality Program Lead - Senior.Key Responsibilities Lead the Supplier Quality function for complex New Product launches Drive the closure of Supplier Quality E...Show moreLast updated: 22 days ago
    • Promoted
    • New!
    Lead Design Engineer

    Lead Design Engineer

    Pentangle Tech Services | P5 GroupNewark, CA, US
    Full-time
    Mechanical Design Lead Engineer - ADAS Sensing.Lucid’s mission is to inspire the adoption of sustainable energy by creating the most captivating luxury electric vehicles, centered around the ...Show moreLast updated: 21 hours ago
    • Promoted
    California Licensed Design Assurance Engineer

    California Licensed Design Assurance Engineer

    VirtualVocationsFremont, California, United States
    Full-time
    A company is looking for a Staff Design Assurance Engineer (Hybrid).Key Responsibilities : Lead Design Control and Software Development initiatives for FDA Class II and Class III medical devices ...Show moreLast updated: 1 day ago
    • Promoted
    Senior Quality Engineer

    Senior Quality Engineer

    VirtualVocationsSanta Clara, California, United States
    Full-time
    A company is looking for a Senior Quality Engineer to provide quality oversight for qualification and validation programs. Key Responsibilities Provide guidance on best practices for qualification...Show moreLast updated: 30+ days ago
    • Promoted
    Lead QA Engineer

    Lead QA Engineer

    VirtualVocationsOakland, California, United States
    Full-time
    A company is looking for a Lead QA Environment Engineer to oversee the implementation and maintenance of Quality Assurance standards and processes for IT projects. Key Responsibilities Lead IT dev...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    VirtualVocationsConcord, California, United States
    Full-time
    A company is looking for a Quality Engineer to join their team focused on Scientific AI applications.Key Responsibilities Take ownership of the QA process and ensure overall product quality Crea...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Assurance Lead Menlo Park, CA +1 locations • Business Development & Partnerships • Prod[...]

    Quality Assurance Lead Menlo Park, CA +1 locations • Business Development & Partnerships • Prod[...]

    MetaMenlo Park, CA, United States
    Full-time
    Quality Assurance LeadQuality Assurance Lead Responsibilities • Build a test-driven engineering culture that drives improvements in quality. Implement process changes to scale testing efforts across ...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Quality Engineer (Hybrid)

    Senior Quality Engineer (Hybrid)

    iRhythm Technologies, Inc.San Francisco, CA, US
    Full-time
    Quality System Compliance activities, supporting equipment management, laboratory compliance and audit readiness at iRhythm Technologies. In this role, you will champion a quality culture mindset by...Show moreLast updated: 8 days ago