Neptune Medical is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. We have already commercialized novel medical devices using our technology. Now the team Triton robotics at Neptune is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Our Triton robot will disrupt flexible endoscopy. Triton Robotic Endoscopy will set a new standard in outcomes for decades to come.
TITLE: Senior Quality Engineer
POSITION SUMMARY:
We are seeking an experienced and detail-oriented Senior Quality Engineer to join our dynamic team in the medical device industry. The Senior Quality Engineer will support all phases of the product lifecycle as products transition from New Product Introduction (NPI) to commercial operations. This role requires a strong understanding of manufacturing processes, regulatory standards, and quality management systems, with a focus on sustaining and improving the quality of products post-release.
The Senior Quality Engineer will collaborate closely with cross-functional teams to drive corrective and preventive actions (CAPA), root cause investigations, process improvements, and regulatory compliance efforts in a highly regulated environment
The ideal candidate will act with passion and intensity in a medical device start-up that is fast-paced and collaborative and will 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.
Essential Duties and Responsibilities:
Technical (Product and Process)
- Develop and implement product and process workflows for best engineering practices.
- Conduct test method transfer and validation activities.
- Develop sampling plans for OQ/PQ activities.
- Trend manufacturing data and contract service providers' results.
- Create validation/re-validation protocols.
- Drive root cause analysis of deviations and complaints.
- Assist in conducting risk assessments and implementing risk mitigation strategies to ensure patient safety and product reliability.
Quality Assurance
- Provide ongoing quality engineering support to manufacturing operations of catheter assemblies, ensuring that products consistently meet internal and external specifications and regulatory requirements.
- Assess, analyze, and trend the quality of incoming materials to reduce variation.
- Lead investigations for non-conformances, product defects, or quality concerns, identifying root causes and implementing corrective and preventive actions (CAPA).
- Analyze manufacturing processes, identify areas for improvement, and lead process optimization initiatives to enhance product quality, efficiency, and cost-effectiveness.
- Provide training and guidance to manufacturing teams on quality-related topics, including process improvements, regulatory requirements, and best practices for maintaining high-quality standards.
- Support internal and external audits and resolve resulting CAPAs.
Supplier Quality
- Participate in audits and performance evaluations of suppliers and contract service providers.
- Manage internal and external suppliers to ensure compliance with product design requirements.
- Track and trend raw material and key component quality.
Regulatory Compliance
- Ensure that all manufacturing processes adhere to relevant regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- Support US and international marketing registration using product expertise.
- Support complaint investigations, health hazard evaluations, and field actions
- Assist with IFU and labeling changes.
Required Education and Experience:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or a related field. A Master's degree is a plus.
- Minimum of 5 years of experience in a quality engineering or manufacturing quality role, preferably within the medical device or regulated industry.
- Demonstrated analytical ability, including root cause analysis, CAPA, and process improvement initiatives.
- Proficiency with personal computers, business software (e.g., MS Office), and technical software (ERP and eQMS systems).
- Experience with design control, change control, and risk management (DFMEA, PFMEA).
Preferred Experience and Qualifications:
- Excellent communication and interpersonal skills, with the ability to effectively present technical information to both technical and non-technical stakeholders.
- Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications
- Experience with Test Method validation, Medical Devices, and Sterilization processes
- Strong technical writing skills and experience with root cause analysis tools
- Experience with various manufacturing processes (machining, molding, joining, forming, additive manufacturing)
Triton Robotics is located in Burlingame, CA, near the Millbrae Caltrain and BART station.
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.
Triton Robotics 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.