Engineer Sr I - Software QA - Design

Requisition ID:                       64845                          Title: Engineer Sr I - Software QA - Design Division: Arthrex, Inc. (US01) Location: Naples, FL

 

 

 

 

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 Senior Engineer – Software QA who is responsible for oversight of quality and risk management throughout the software lifecycle, and independently audits the adequacy of design specifications, Verification &Validation test plans, and reliability test plans for products.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and 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.

Education and Experience:

• 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.

 

Knowledge and Skill Requirements/Specialized Courses and/or Training:

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

Reasoning Ability: 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.

Mathematical Skills: Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills: 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.

 

 

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 Medical Clinics
• Free Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)