R&D Manager, Mechanical Design

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.

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.