Sr. Engineer ; Mechanical - Product Improvement - I&R

This Sr. Engineer I (Mechanical) – Product Improvement – I&R position is based at our Ave Maria, FL manufacturing facility.

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics.

We are searching for a Sr. Engineer I who will provide ongoing product improvement and sustainment engineering support for our medical devices. The engineer will analyze, design, test, verify, and sustain product improvements to ensure safety, quality, and regulatory compliance.

• Designs components and/or functional systems primarily by modifying existing designs to develop or improve product functionality and durability while facilitating manufacturing operations to meet engineering design intent.
• Analyzes customer feedback to identify common issues and areas for enhancement, reviews failure modes on the operations lines and of returned devices, and performs root cause investigations to recommend design and development alterations to improve product quality and/or procedures.
• Acts as the primary mechanical design resource on multifunctional product support teams, as assigned by the Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, verification, release, and sustaining, adhering closely to project timeline and budget.
• Works closely with cross-functional teams, including Design, Manufacturing, Service, Repair, Quality, Supply Chain, etc., to ensure the design considers the needs of internal stakeholders.
• Supports the creation of Manufacturing and Service processes (assembly/disassembly/rework), ensuring design intent is maintained.
• Determines the necessity of testing and performs or oversees rigorous verification testing and validation of product improvements to ensure they meet safety, quality, and regulatory standards for assigned products.
• Maintains comprehensive documentation of all product changes and improvements, including design specifications, test results, and validation reports.
• Works with Systems Engineering to maintain an accurate design history file for assigned projects, adhering to Arthrex design control procedures.
• Works with project management and extended team to determine timelines for assigned projects and reports the progress of assigned projects on a timely basis.
• Provides Regulatory department technical support for assigned projects as needed.
• Supports Marketing and Product Management with technical information for training and marketing assigned products.
• Implements continuous improvement methodologies to enhance product development processes and outcomes.
• Attends surgical observations (live surgery, wet labs, and/or dry labs) to gather input from end users and identify opportunities for product improvements, and may be required to travel to attend trade shows and/or training events.

• Bachelor’s Degree in Mechanical Engineering or equivalent is required (MS Preferred).
• 5 Years of full-time job experience in Mechanical Engineering (excluding internships and/or academic programs).

• 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 preferred.
• Expert in designing products using a 3D-CAD program required (Solid Works preferred).
• Expert level application of 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 perspective preferred.
• Expert level application of one or more design simulation and/or 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.

• Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices and regulations.
• Develops design solutions to…