Engineer Sr II - Mechanical - Medical Devices

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineer Sr II - Mechanical will be responsible for the full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.  

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 the 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 the 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 files for assigned projects, adhering to Arthrex 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 processes maintain design intent.
• Supports surgeon and distributor customers by training and/or educating them on technical aspects of assigned products as needed.
• Determines the necessity of testing and initiates testing of assigned products
• Reports 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.
• May be required to travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Knowledge:

• Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices and regulations.
• Develops design solutions to complex problems at the system level, which require the regular use of analysis, ingenuity, and innovation. Ensures solutions are consistent with organization objectives.

Reasoning/Ability:

• Develops systemic design solutions to a variety of complex problems. May refer to established precedents and policies. Demonstrates a command of engineering skills through the ability to efficiently design intrinsically safe and effective solutions.
• Effectively communicates the motivation, theory, and practical trade-offs of designs and eagerly work with a multi-disciplinary team to realize the best overall solution.
• Has and maintains a healthy sense of risks and skepticism when developing designs, plans, and test strategies.
• Maintains a well-organized catalog of historical risks which guides their design choices.
• Work is performed without appreciable direction.

Discretion/Latitude:

• Participates in determining objectives of assignments.
• Plans, schedules, and arranges own activities, direct reports (if applicable), and team resources to accomplish objectives.
• Work is reviewed upon completion for adequacy in meeting objectives.

Skills:

• Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
• Manufacturing process knowledge required.
• Project management and communication skills required.
• Working knowledge of anatomy from an orthopedic standpoint is preferred.
• Expert in designing products using a 3D-CAD program required (SolidWorks preferred).
• Expert-level application of the latest ASME Y14.5 standard.
• Expert-level application of tolerance analysis (stack-up) methods.
• Technical knowledge in development methodologies, design, and project implementation required.
• Knowledge of orthopedic surgery principles, theories, products, and historical perspectives preferred.
• Expert-level application of one or more design simulation and/or analysis tools (FEA, CFD, optical ray tracing, etc.) and appropriate methods to validate results.
• Proficient with Design for Quality tools such as FTA, FMEA, and HALT/HASS.

Education:

• 8 Years of full-time job experience in Mechanical Engineering (excluding internships and/or academic programs).
• BS Degree in Mechanical Engineering required (MS Preferred).