R&D Manager, Mechanical Design

About the Company

Neptune Medical is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA. The team is building Triton Robotic Endoscopy, a fully flexible medical robot designed to disrupt flexible endoscopy and set new standards in patient outcomes.

Responsibilities

• Manage 5-7 direct reports, including career development and performance reviews
• Plan team staffing and recruitment to ensure project success
• Drive performance and technical requirement development
• Lead risk management activities
• Provide project management for device handles development, including defining milestones and cross-functional interdependencies
• Represent the team in updates to senior management
• Work with NPI to develop processes and device assembly procedures
• Lead vendor selection activities for tooling, component, and subassembly sourcing
• Upgrade manufacturing processes to ensure proper DFM and scalability
• Implement programs to continuously improve quality, cost, and cycle time
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations

Requirements

• B.S. or M.S. in Mechanical or Related Engineering
• 8+ years of work experience
• 2+ years in a technical leadership or management role
• Demonstrated experience working with cross-functional teams
• Experience developing and launching high volume medical devices
• Proficiency in CAD modeling, engineering drawing generation, DFM, tolerance analysis, and tooling design
• Experience creating and managing schedules, budgets, and plans
• Solid understanding of design controls and risk management

Preferred Qualifications

• Experience managing engineers, technicians, or interns as direct reports
• Experience with disposables/consumables
• Experience with design and sourcing high volume injection molded components
• Proven track record of developing products from invention to market release
• Experience in a start-up environment
• Proficiency with SolidWorks