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. 

Essential Duties and Responsibilities:

• 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.

Education/ Experience:

• 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).

Knowledge:

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

Skills:

• 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 (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.

Reasoning Ability:        

• 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 skepticism when developing design, plans, and test strategies.
• Maintains a well-organized catalog of historical risks which guides their design choices.

Discretion/Latitude:

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

Incidental Duties:

• The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Language and Communication Skills:

• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. 
• Ability to verbally communicate ideas and issues effectively to other team members and management. 
• Ability to write and record data and information as required by procedures.

Physical Demands:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. 

Vision Requirements:

• Visual acuity necessary to do the job safely and effectively. 

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

Arthrex Benefits

• Medical, Dental and Vision Insurance
• Company-Provided Life Insurance
• Voluntary Life Insurance
• Flexible Spending Account (FSA)
• Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
• Matching 401(k) Retirement Plan
• Annual Bonus
• Wellness Incentive Program
• Free Onsite Lunch
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Paid Sick Leave
• Volunteer PTO
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.