Senior Operations Quality Engineer

Title:  Senior Operations Quality Engineer

Summary:

Neptune Medical (NM) is a venture-backed medical device company based in Silicon Valley. We are the developer of the proprietary Dynamic Rigidization™ technology that instantly toggles thin-walled tubes such as overtubes and catheters between flexible and rigid states. We have commercialized our first overtubes for the diagnosis and treatment via a variety of endoscopic procedures. We are seeking a compelling candidate to join the GI operations quality team.  The ideal candidate would display the ability to perform the below requirements, would show a high level of individual responsibility, and would act with passion and intensity in a VC-funded medical device start-up that is fast-paced and collaborative. 

The Senior Operations Quality Engineer will support/lead Quality Assurance activities in conjunction with Manufacturing Operations for the Pathfinder franchise. Additional responsibilities will include managing / mentoring junior engineers and/or quality specialists.

Essential Duties and Responsibilities 

• Working in conjunction with the Manufacturing Operations group, directly responsible for range of Quality System processes focused on Production and Process Controls, including Receiving Inspection, Nonconforming Materials, Risk Management, Process and Equipment Validations (IQ/OQ/PQ), Design for Manufacturability (DFM), Environment (Controlled Environment Room) qualification and/or monitoring, Supplier Controls and Data Analysis. 
• Lead the establishment or revision of the Risk Management File related activities (pFMEAs, Hazard Analysis, Risk Plans, Risk Reports) for new product introductions, sustaining, and commercially released product per ISO 14971. 
• Review of Engineering Change Orders of specifications, process and inspection instructions for impact to manufacturing quality and compliance.
• Review of Nonconforming Material Records (NCMR) for impact to manufacturing quality and compliance.
• Mentor teams on equipment qualification, inspection method selection, test method verification, sample creation and selection, statistical techniques, etc. 
• Ability to effectively work with external contractors and vendors / contract manufacturers, as needed, including issuance of Supplier Corrective Action Request (SCAR).  
• May participates in regulatory activities, including FDA 510(k) and Technical File creation, review and submission. 
• Complies with the company’s Quality Management System procedures, instructions, forms and records to meet regulatory requirements. 
• Manage quality specialists and provide day to day guidance.

Required Education and Experience 

• Bachelor’s degree in Engineering or another technical or scientific discipline. 
• 5+ years of related experience, including working with a Class II medical device. 
• Hands-on problem solving ability.
• Prior working experience in full-lifecycle, regulated medical device engineering programs and processes. 
• Structured medical device product manufacturing / operations experience in requirements-driven engineering, documentation, rigorous verification, etc. 

Preferred Experience and Qualifications

• S. in Engineering or another technical discipline, or equivalent experience. 
• Recognized Quality certification(s) (ASQ Certified Quality Engineer, internationally recognized Quality Auditor certification, etc.). 
• 7+ years of related experience, including working with sterile, Class II-III medical devices, for consideration of a Staff level position. 
• Strong understanding of ISO 13485:2016 and EU Medical Device Regulations, FDA 21CFR Part 820 and ISO 14971:2019 Application of Risk Management. 
• Prior training and use of Statistical Process Controls (SPC), Lean Six Sigma, and/or Design of Experiments (DOE).
• Able to clearly identify, define, and communicate technical, process, and quality related issues or improvements with internal and external personnel. 
• Able to create and execute training for team members on quality processes and systems.
• Past Supplier Quality Controls experience, including with Contract Manufacturing.
• Demonstrated skills in managing priorities and coordinating team activities while supporting and executing cross-functional team decisions in a small company / startup environment. 
• Ability to adapt to uncertain situations. 
• Prior mentoring capabilities and people management skills.

Compensation: our job titles may span more than one career level. The starting base pay for this role is between $139,000-$170,000 for Senior Engineering roles. The actual base salary is dependent upon many factors, such as: 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 bonus, equity, and benefits.

We are an Equal Employment Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, marital status, national origin, protected veteran status, disability, or any other legally protected class.