Senior Quality Engineer

Triton Medical Robotics, a division of 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 at Triton is building something truly unique: a fully flexible medical robot that enables doctors to reach deep into human anatomy. Our robot will disrupt flexible endoscopy and 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 effectivel