Managing Staff Mechanical Design Engineer

Managing Staff Mechanical Design Engineer

Requirements

• Demonstrated excitement and capacity to learn and quickly review/analyze tough technical problems using fundamental principles, exceptional mechanical intuition, and persistence to pinpoint root cause of problems
• Demonstrated ability to think at a systems level, interface between multiple design groups, and negotiate conflicting requirements
• Passion for supporting continuous improvement
• Understanding concepts of design input, design output, requirement traceability, and FMEA risk analysis
• Demonstrated commitment and ability to design reliable, high quality, and manufacturable products
• Mechanical analysis, including statics and strength of materials
• Exposure to full product development lifecycle including ideation, design, analysis, debug, verification, qualification, transfer to manufacturing, and sustaining
• Demonstrated knowledge of materials (especially plastics and silicone rubber) and material properties. Ability to apply knowledge of engineering materials and component selection criteria to product designs through exceptional concept development, hands-on prototyping, and reliability testing skills.
• Experience designing plastic components and assemblies
• Knowledge of component manufacturing processes (including injection molding, thermoset molding, machining, vacuum thermoforming, pad printing, laser marking, etc.)
• Proficiency with CAD (SolidWorks highly preferred): designing parts with complex geometry, creating assemblies, creating detailed manufacturing drawings, and examining designs with Finite Element Analysis (FEA)
• Proficiency at failure analysis, including root cause analysis techniques (e.g., fishbone, 5 Whys, etc.)
• Fluency in ASME Y14.5 GD&T and tolerance stack analysis
• Comfortable operating measurement and test equipment
• Demonstrated ability to create and execute an engineering test plan, and proficiency at writing engineering test reports
• Ability to communicate effectively (written, oral) across functions, including presenting to a technical audience
• Minimum 12 years of hardware product design experience with undergraduate degree; minimum 8 years with graduate degree
• Minimum 3 years of experience leading product development teams or managing individual contributors, with proven ability to succeed in a team environment
• Prior experience working in medical device or other regulated industry
• Ability to travel up to 10% per year

Responsibilities

• Manage a group of 2 to 5 entry- and senior-level mechanical engineers, including assessing and coaching employee performance, and investing in mentorship and training
• Provide vision for the engineering team and foster an environment that encourages creativity, risk-taking, and crisp execution, while building a solid foundation upon which to launch new designs
• Navigate complex technical and programmatic situations by driving timely decision-making and setting appropriate priorities to focus the team for success
• Manage, support and influence cross-functionally to optimize performance, manufacturability, and reliability of existing Da Vinci SP Accessories, with careful consideration for critical functions and safety
• Observe clinical cases and participate in interviews with clinical experts to ensure product designs provide value to patients, physicians, and hospitals
• Establish group priorities and team member work goals consistent with overall project and company goals
• Advocate best practices for mechanical design and ensure engineers follow Design Control guidelines per company and regulatory requirements, including formal design reviews
• Communicate project status and key metrics to senior management, including identifying technical and business risks
• Assist with planning, staffing, budgeting, and project/program cost tracking

Preferred Qualifications

• Ability to handle ambiguity and oversee multiple projects at once
• Knowledge of ISO requirements (especially risk management) and GMP guidelines. Experience with FDA regulations and medical device design control a plus
• Knowledge of sterilization methods, biocompatibility, and packaging of medical devices
• Knowledge/understanding in additional manufacturing processes such as extrusion, blow molding, ultrasonic welding, RF welding, heat staking, and laser welding