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Arthrex · 1 day ago

Engineer Sr I - Software QA - Design

Naples, FL

Full-time

Onsite

Senior Level

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 Senior Engineer – Software QA responsible for overseeing quality and risk management throughout the software lifecycle and auditing design specifications and test plans for products.

Health CareMedical Device

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Ensures that appropriate Software (SW) Quality plans are made that include all stages of the software life cycle and support SW Quality Plan design

Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs)

Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design-related activities during the software lifecycle

Can lead quality-related problem-solving for software

Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required

Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards

Qualification

Software Quality AssuranceSDLC for medical devicesISO 13485 complianceSoftware Risk ManagementCodebeamerJiraConfluenceCI/CDDevOpsMathematical skillsEnglish communication

Required

Bachelor's degree in Engineering or Computer Science required

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

Working knowledge of SDLC for software in medical devices

Display working knowledge and provide guidance to design teams on ISO 13485, MDSAP, IEC 62304, IEC 62366 for potential compliance gaps

Experience with Codebeamer, Jira, Confluence, CI/CD and DevOps, SAP, Agile tools such as: configuration management, source control, unit testing, etc

Experience in Software Risk Management

Working knowledge of appropriate global regulations, requirements, and standards for SiMD & SaMD, including Machine Learning

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 the English 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 in English to other team members and management

Ability to write and record data and information as required by procedures in English

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

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Trends of Total Sponsorships

2025 (30)

2024 (22)

2023 (13)

2022 (13)

2021 (9)

2020 (12)