Job Description

Organization

SMEDIX INC.

Job Location

SAN DIEGO, CA

Job Description

SMEDIX, Inc. has an exciting opportunity for a Software Test Automation Engineer with Python experience who shows initiative towards improving the quality of software solutions for our clients in the medical devices and life science tools industries. This role will demonstrate strong technical leadership within a bioinformatics team working remotely.  This role will work with Bioinformatics SQA (software quality assurance) engineers and members of a bioinformatics group to ensure the quality of bioinformatics software used in an FDA regulated environment.

The role would suit a highly motivated, curious and detail-oriented test engineer with a track record of delivering customer-focused software in a regulated environment. Most importantly you will have an opportunity to be part of a company focused on helping our global healthcare clients deliver software solutions to improve patient care.

Light business travel (< 10%) can be expected should working from home restrictions be lifted sometime during the first 6 months.

Key Responsibilities

·       Potentially write software requirements and designs to maintain alignment with user needs and design inputs.

·       Writing verification plans, protocols and reports

·       Writing IQ/PQ procedures, Software Configuration Management, COTS Documentation (3rd party tools)

·       Design and review test cases to ensure verification coverage of software requirements, accuracy, and correctness.

·       Extracting traceability matrices from JAMA

·       Execute test cases and produce verification evidence and reports.

·       Ensure identified bugs are recorded, tracked and verified.

·       Develop and review automated test code and scripts.

·       Make sure that software is verified in compliance with the relevant quality management system and medical device standards.

·       Provide technical leadership and occasional mentorship to the verification and validation engineering team.

Requirements

·       2+ years of experience and strong technical competency in software testing

·       2+ years of experience and strong technical competency in Python

·       Practical experience with test automation tools such as Cypress, Selenium, Pytest, Unittest.

·       Excellent written and verbal communication skills. 

·       Firm knowledge of different phases of software testing and software development life cycle including Agile Methodology (SCRUM).

Desirable

·       2+ years of experience with Docker and working within Linux environment.

·       Proficient in Robot Framework, Keyword driven development, and Gherkin testing

·       Knowledge of Medical Device regulations (ISO 13485, IEC 62304, etc.) as they pertain to verification and validation.

·       Use of Jama or similar for requirements management.

·       Experience with GitHub or other version control systems.

·       Foundation ISEB/ISTQB Certification in Software Testing (or equivalent).

Education

·       Bachelor of Science in Computer Engineering, Computer Science or equivalent