R&D Manager, Mechanical Design

Position Summary

The Product Development Manager, Mechanical Design will manage a group of engineers developing the drive mechanism and interface to robotic capital equipment for a novel robotic endoscopy system.

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.

Roles and 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, cross-functional interdependencies, risks, and opportunities to expedite launch timelines
• Represent 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 our manufacturing processes to ensure proper DFM and maximum scalability of our medical devices
• Initiate and implement programs to continuously improve quality, cost and cycle time
• Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure GMP.
• 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.

Required Qualifications

• B.S. or M.S. in Mechanical or Related Engineering
• 8+ years of work experience
• 2+ years in technical leadership or management role
• Demonstrated experience working with cross functional teams
• Experience developing and launching high volume medical devices
• Capable with 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
• Developed products from invention to market release
• Experience in a start-up environment.
• Proficient with SolidWorks.

Neptune Medical is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Pay and benefits

Our job titles may span more than one career level. The starting base salary for this role is between $180,000 and $231,000 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.