Apply on Employer Site

Dexcom Deutschland GmbH · 3 days ago

Software QA Engineer 2

Portland, OR

Full-time

Onsite

Entry, Mid Level

$75K/yr - $125K/yr

2+ years exp

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM), aiming to improve health outcomes through innovative technology. The Software QA Engineer 2 will provide guidance on regulatory standards, ensure compliance in software development, and support various cross-functional teams in quality assurance processes.

Medical Device

Responsibilities

You will actively participate as a core team member of the R&D Quality Assurance Engineering team

You will provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and other relevant regulations worldwide to the cross-functional teams

You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams

You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA

You will provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations

You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)

You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables

You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained

You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges

You will assume and perform other duties as assigned

Qualification

IEC 62304ISO 13485ISO 1497121 CFR 820Medical Device experienceSDLC processesAgile Software DevelopmentSoftware Quality EngineeringSoftware development experienceSoftware test experienceRisk managementCyber Security knowledgeASQ CSQE certificationCommunication skillsTeam collaborationProblem-solving skills

Required

Experience working with software mobile applications

Medical Device experience in compliance with the requirements of FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971

Knowledge and experience with SDLC processes along with software development methodologies such as Agile Software Development, Waterfall Model

Software Quality or Engineering experience in Requirements Analysis, Design/Development, Product Integration and Test

Proficiency to interpret software design and code to verify implementation of requirements

Software development and/or Software test experience

Ability to understand complex tasks and goals. Drive projects to completion with limited supervision

Ability to communicate and present to all levels of management

Typically requires a Bachelor's degree in a technical discipline, and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience