Mechanical Engineer – Product Engineering

Mechanical Engineer – Product Engineering

Requirements

• Demonstrated excitement and capacity to learn and quickly analyze tough technical problems using fundamental principles, strong 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 continuous improvement and a commitment to quality
• Understanding concepts of design input, design output, requirement traceability, and FMEA risk analysis
• Mechanical analysis, including statics, dynamics, and strength of materials
• Demonstrated ability to design for reliability and manufacturability
• Exposure to full product development lifecycle including ideation, design, analysis, debug, verification, qualification, transfer to manufacturing, and sustaining
• Demonstrated knowledge of materials (preferably plastics and silicone rubber) and material properties. Ability to apply knowledge of engineering materials and component selection criteria to product designs through strong concept development, analysis, 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 strongly preferred): designing parts with complex geometry, creating assemblies, creating detailed manufacturing drawings, and analyzing 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 machine shop, 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 and verbal) across functions, including presenting to a technical audience
• Minimum 4 years of hardware product design experience with undergraduate degree, or minimum 2 years with graduate degree
• Ability to travel up to 10%

Responsibilities

• Work within multi-disciplinary teams to design, develop, and document mechanical components and assemblies for surgical system accessories, including parts made by plastic injection molding, thermoset compression molding, and machining
• Review and define functional requirements based on user and product-level requirements and international standards, and maintain Design History Files per regulatory and corporate requirements
• Analyze risk of component failure (FMEA) and implement effective mitigations
• Create and maintain product specifications (including engineering drawings) with careful consideration for critical functions and safety while designing for manufacturability and cost, in accordance with corporate operating procedures
• Troubleshoot issues and get to root cause quickly using thorough and logical methods
• Iterate design solutions rapidly by prototyping, testing, and analyzing using engineering principles and techniques, including computer simulation and physical models
• Support and participate in clinical and human factors evaluations to ensure positive user experience
• Collaborate with manufacturing and supplier engineering to facilitate transfer of designs into sustainable production
• Establish individual goals aligned with overall project and company goals

Preferred Qualifications

• Sense of shared responsibility and reward
• Ability to excel in a fast-paced, high transaction, mass-production environment
• Ability to utilize deep technical knowledge and broad expertise to achieve company objectives in creative and effective ways
• Experience leading cross-functional meetings
• Knowledge of sterilization methods, biocompatibility, and packaging of medical devices
• Knowledge of additional manufacturing processes such as extrusion, blow molding, ultrasonic welding, RF welding, heat staking, and laser welding
• Prior experience working in a regulated industry (medical device strongly preferred)