Software Quality Engineer/Technical Writer

Job Description:

The Software Quality Engineer/Technical Writer will be responsible to perform software quality assurance activities and write Software Development life cycle documentation or related content.

The position is responsible for ensuring that in-house developed software applications have been effectively verified and validated prior to their release for shipment/501K clearances and that these designs effectively meet documented and implied user needs and requirements. Software quality assurance efforts are life cycle oriented beginning during product requirements development and continuing throughout its lifetime.

This position will also continue to improve the overall quality of software, including software hazard analysis, requirements traceability, defect racking, configuration management, and software tool validations.

 

Essential Duties and Responsibilities:

  • Develop test plans and protocols for proof performance for software applications used in the design of medical device.
  • Generate and execute test plans and write Validation reports to meet design control standards.
  • Work closely with the software development team to clarify measurable software requirements, identify software hazards and test controls, identify and correct defects that are found during various stages of testing.
  • Develop and maintain test database, test set up used for validation of software revisions and the integration with upstream/downstream applications.
  • Work with stakeholders to review, analyze and complete application documentation and software quality deliverables – user needs, requirements, design documents, user manuals, risk assessments, project and validation plans.
  • Work with Regulatory Affairs to prepare documentation for FDA 501K submissions.
  • Other responsibilities as assigned.

Qualifications:

  • BS in Engineering/technical or Quantitative field, Computer Science or similar field; 3+ years hands on experience in software quality assurance and strong writing skills in regulated industry and/or equivalent combination of education and experience.
  • Experience working with products from the prototype through 501K/ISO clearance and commercialization is preferred.
  • Thorough understanding of software quality assurance principles, practices and metrics as well as software development and testing best practices that foster high quality software.
  • 3+ years preparing submission-grade software documentation working directly with software developers/RA/QA to obtain raw information for transformation into usable documentation.

Skills, Abilities, Competencies Required:

  • Superior written and verbal communication skills.
  • Able to understand Software development requirements and thus develop efficient testing data set up, test plans and execute on them.
  • SolidWorks or any 3D modeling software experience preferred.
  • Able to work accurately and independently in a fast-paced, hectic, ever-changing environment with strong attention to detail.
  • Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
  • Strong organizational, analytical and time-management skills.
  • Align with project schedules and complete assigned tasks on time.
  • Able to self-motivate and work both independently and as part of a team.
  • Knowledge of software quality engineering and testing methods at all levels (unit, integration, system) V&V, acceptance) applied within the software development life cycle.

Work samples: Please submit 2 examples of the following original technical documentation: Software Requirements (if authored), Software Validation Plan and Software Validation Summary Report.  Samples should demonstrate instructional clarity, organizational skill, and concise writing style.

ConforMIS is an Equal Opportunity Employer

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