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Arthrex · 3 days ago

Engineer II QA Design - Sustaining

Naples, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineer II contributes to post-launch design-related activities while interfacing with engineering teams and manufacturing facilities, focusing on product sustainability and quality assurance.

Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Support Design Quality Engineering efforts on product sustainability of released products to the market

Review production specifications, when requested by manufacturing, to clarify requirements, establish practical inspection methodologies, and/or improve product requirements for the overall manufacturability of products with the support of Design Engineering and manufacturing facilities

Ensure Essential Design Outputs remain under appropriate manufacturing process control throughout the product lifecycle

Perform root cause investigation as part of improving product quality/performance issues as a result of design failure modes stemming from product design and/or manufacturing process

Maintains understanding and regulations/standards from product release through product retirement, acting as a resource to other functional groups, within the product design change process

Support product risk assessment activities through application of a working knowledge of applicable standards (e.g., ISO14971, etc.) and tools such as (application, design, process) FMEAs, FTA, and Hazard Assessment

Lead the enhancement and continuous improvement of the Risk Management processes for medical devices, including the creation, oversight, and global harmonization of policies and procedures

Display working knowledge in the area of usability/human factors engineering principles including standards (IEC 62366) and FDA guidance for compliance

Facilitate the planning, execution, and review of verification/validation (v&v) activities including assessment of adequate inputs to the v&v process

Provide direction on how to perform Test Method Validations, where appropriate, leads efforts to reduce test method bias ensuring a robust accept/reject process. It could require training of manufacturing personnel in appropriate test procedures, inspection methods, and interpretation of results

Provide statistical techniques for appropriate product testing strategies in alignment to risk levels estimated from the Risk Management process

Support NCRs and CAPAs related to design and/or inspection/test methods

Qualification

Design Quality EngineeringRisk ManagementISOFDA standardsSix SigmaLean methodologiesGD&TDOESAPAgileMathematical skillsTime managementProblem-solvingCommunication skills

Required

Bachelor's degree in Engineering required

2+ years design assurance / quality assurance experience in a medical device or other highly regulated industry required

Working knowledge of ISO and FDA design and development quality requirements

Technical and working knowledge in Six Sigma and Lean methodologies

Proficiency in assessing manufacturing quality requirements

Proficiency with PC operations, and the Microsoft Office suite, and CAD/CAM Software

Ability to define problems, collect data, establish facts, and draw valid conclusions

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements

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

Visual acuity necessary to do the job safely and effectively

Preferred

Biomedical, Mechanical, or Electrical Engineering degree

Technical knowledge in development methodologies, and project implementation, including but not limited to, GD&T & DOE

Hands on experience with SAP and Agile

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 Medical Clinics

Free Onsite Lunch

Tuition Reimbursement Program

Trip of a Lifetime

Paid Parental Leave

Paid Time Off

Volunteer PTO

Employee Assistance Provider (EAP)

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)