Job Description

Software Quality Engineer

Growing Startup, Mixed Reality Surgical Navigation 

Direct hire, can be based in Dallas or Miami based

This role is ideal for someone with 5+ yrs. Software quality engineer experience

PolarisAR Inc Location: Richardson, Tx, Miami, Fl. PolarisAR, mission is to create a new class of mixed reality surgical technology. It utilizes spatial computing to create a holographic navigation system. This unique mixed reality approach allows surgeons to measure, plan, adjust and guide surgical technologies used during total joint replacement procedures. The intended outcome is to achieve clinical accuracy currently attainable only by total joint robotic systems in a mixed reality format. 

A Mixed Reality headset is used as a spatial computing tool and not merely to project holographic displays. This requires building advanced mapping algorithms to dynamically acquire and link anatomic data specific to each individual patient. This guides the restoration of normal biomechanics and improvement in functional outcomes. PolarisAR, Inc. provides total joint solutions under its proprietary names – Polaris Knee, Polaris Shoulder and Polaris Hip. 

Responsibilities

•Ensure appropriate regulations, such as 21 CFR Part 11, 820, cGMP regulations and IEC 62304, are addressed in validation

•Coordinate, assist and document validation activities; preparation/approval of protocols and reports

•Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls

•Assist validation activities of cross functional teams that include technical functions such as Engineering, Manufacturing and Marketing, 

Requirements

The successful candidate will have a Bachelors’ degree in Engineering, knowledge of continuous improvement methodologies, and manufacturing

•Bachelor’s degree in computer science, technology or related field required

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

•Thorough understanding of FDA regulations and software validation guidance documents

• Experience in the validation of software life cycle IEC 62304 

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

• Excellent communication skills and customer service orientation

PolarisAR offers a competitive compensation package that includes, base salary, bonus based on company performance, stock options, great health insurance coverage including dental and vision, three weeks Paid Time Off, and a 401k plan

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status