Senior Engineer – Software QA – Design
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Naples • Florida • United States
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- 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.
Requirements
- 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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
design assurancequality assurancesoftware lifecycleISO 13485MDSAPIEC 62304IEC 62366Software Risk Managementpost-market analyticsstatistical analysis
Soft skills
problem-solvingdata collectionanalytical skillstechnical interpretationmathematical comprehensioncommunicationwriting skillsteam collaborationleadershipbusiness partnership