Senior Design Assurance Quality Engineer

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.