Neptune Medical
Senior NPI Process Development Engineer
Burlingame, California, United States · Senior
Sponsorship not specifiedDetected 91 days ago
AgileCustomer SupportGMPFDA RegulatoryMedical DevicesCollaborationMicrosoft OfficeOSHATolerance Analysis
About the role
- 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.
- Upgrade our manufacturing processes to ensure proper DFM and maximum scalability of our medical devices
- Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
Responsibilities
- Work with product development to design and prototype novel manufacturing processes and equipment
- Develop new processes to manufacture our products to meet device performance and cost targets.
- Design and prototype novel manufacturing equipment and fixturing
- Create and maintain necessary Manufacturing Process Instructions (MPI's), test methods, product drawings, and component specifications
- Initiate and implement programs to continuously improve quality, cost and cycle time
- Provides technical support and performing failure analysis for non-conforming components, assemblies, and process defects
- Build the assembly line for our clinical launches
- Manage the flow of WIP through Lean practices including Kanban and 5S.
- Maintain relationships with key vendors and suppliers and support supplier validations and supplier management best practices.
- Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and any other applicable domestic regulations including Cal FDB, OSHA and Cal-OSHA.
Requirements
- 4+ years of work experience
- Possess knowledge of process validation, GMP, and state-of-the-art manufacturing processes
Nice to have
- Experience with catheter or similar manufacturing (lamination, bonding, dip coating, ultrasonic welding, etc)
- Experience with disposables/consumables
- Experience managing lab technicians and assemblers.
- Developed products from invention to market release.
- Experience in a start-up environment.
- Proficient with SolidWorks.
- Experience creating and managing schedules, budgets, and plans.
- Experience with packaging and shipping validations
Compensation
- The starting base salary for this role is between $140,000 and $175,000 depending on experience.
Benefits
- Specify, support and maintain the proper CER space to manufacture our medical devices under defined environmental quality controls.
Company info
- 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.
- Senior NPI Process Development Engineer
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This listing is sourced directly from Neptune Medical's careers page and normalized into a canonical job model.