Our client is a global medical device company and a leader in new product development and medical education in orthopedics. This position is responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. The company is open to a hybrid / remote working model for this position.

Essential Duties and Responsibilities

• Designs components or functional systems and modifies existing designs to develop or improve products as well as facilitate manufacturing operations
• Recommends alterations to development and design to improve quality of products and/or procedures
• Works with finance and extended team to determine budget for assigned projects
• Works with project management and extended team to determine timeline for assigned projects
• Primary mechanical resource on multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget
• Works with Systems Engineering to create and maintain design history file for assigned projects, adhering to the client’s design control procedures
• Provides Regulatory department technical support for assigned projects as needed
• Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products
• Works with extended team to ensure design considers the needs of internal stakeholders (Manufacturing, Service, Quality, Sourcing, etc.)
• Supports Manufacturing and Service process creation (assembly/disassembly /rework), ensuring process es maintain design intent
• Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed
• Determines necessity of testing and initiates testing of assigned products
• Report’s progress and status of assigned projects on a timely basis
• Regularly attends surgical observations (live surgery, wet labs, and / or dry labs) to gather input from end users and identify opportunities for product improvement

Requirements

• Knowledge of FDA and ISO guidelines for the development of medical devices preferred
• Manufacturing process knowledge required
• Expert in designing products using a 3D-CAD program required (SolidWorks preferred)
• Proficient with latest ASME Y14.5 standard.
• Proficient with tolerance analysis (stack-up) methods
• Technical knowledge in development methodologies, design, and project implementation required
• Knowledge of orthopedic surgery principles, theories, products, and historical perspective preferred
• Proficient with one or more design analysis tool (FEA, CFD, optical ray tracing, etc.) and appropriate methods to validate results
• Proficient with Design for Quality tools such as FTA, FMEA, HALT/HASS
• Years of full-time job experience in Mechanical Engineering (excluding internships and/or academic programs) BS Degree Mechanical Engineering required (MSPreferred)