Sr. Mechanical Engineer - Product Improvement - I&R

Overview

Requisition : 63743 Title
:
Sr. Mechanical Engineer I - Product Improvement - I&R Division
:
Arthrex, Inc. (US01)
Location
:
Santa Barbara, CA Salary Range
: Salary Minimum
: $
Salary Maximum
: $

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Mechanical Engineer I – Product Improvement to support our Imaging & Resection team. This individual will be responsible for ongoing product improvement and sustainment engineering support for medical devices, including analysis, design enhancements, implementation, verification, and sustaining activities to ensure product quality, reliability, and compliance throughout its lifecycle.

Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

This position will be based out of our Santa Barbara, CA location.

• 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
• 5 Years of full-time job experience in Mechanical Engineering (excluding internships and/or academic programs).

• Complete understanding and application of principles, concepts, practices, and standards.
• Full knowledge of industry practices.

• Knowledge of FDA and ISO guidelines for the development of medical devices preferred.
• 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).
• 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.

• Develops solutions to a variety of complex problems.
• May refer to established precedents and policies.
• Develops 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…