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Arthrex · 12 hours ago

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

Santa Barbara, CA

Full-time

Onsite

Mid, Senior Level

$121K/yr - $196K/yr

5+ years exp

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. They are seeking a Sr. Mechanical Engineer I – Product Improvement to support the Imaging & Resection team, focusing on ongoing product improvement and sustainment engineering for medical devices. The role involves design enhancements, implementation, verification, and ensuring product quality and compliance throughout its lifecycle.

Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

3D-CAD designFDAISO guidelinesManufacturing processesProject managementASME Y14.5 standardsTolerance analysisDesign analysis toolsOrthopedic anatomy knowledgeTechnical knowledgeCommunication skills

Required

Bachelor's Degree in Mechanical Engineering or equivalent

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

Manufacturing process knowledge

Project management and communication skills

Expert in designing products using a 3D-CAD program

Proficient with latest ASME Y14.5 standard

Proficient with tolerance analysis (stack-up) methods

Technical knowledge in development methodologies, design, and project implementation

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

Preferred

Knowledge of FDA and ISO guidelines for the development of medical devices

Working knowledge of anatomy from an orthopedic standpoint

Knowledge of orthopedic surgery principles, theories, products, and historical perspective

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)

Deferred Compensation Plan (DCP)

Company

Arthrex

Glassdoor4.0

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

Founded in 1981

Naples, Florida, USA

10001+ employees

https://www.arthrex.com/

H1B Sponsorship

Arthrex has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (30)

2024 (22)

2023 (13)

2022 (13)

2021 (9)

2020 (12)