OPPORTUNITIES

Senior Software Quality Engineer

The Senior Software Quality Engineer (SQE) is responsible for providing leadership and insight as appropriate during new product development to ensure that the design, development and verification of software complies with product specifications and regulatory requirements.  Works closely with software development engineers to refine software requirement specifications and develops test plans and protocols.  Plays a key role in providing guidance and direction on acceptability of software quality deliverables prior to clinical studies and market release.

 

Primary Responsibilities

  • Participates in new product development projects to ensure software used in the development and manufacture of medical device systems is developed, deployed and maintained in accordance with company and regulatory requirements.  Able to generate appropriate software development life cycle deliverables.
  • Participates in software development processes, software requirements analysis and software documentation, including but not limited to Software Requirements Specification, Software Design Description, Software Test Plans and Software Test Procedures.
  • Develops both automated software tests and manual software test protocols to ensure that software complies with performance, safety and regulatory requirements.  Promotes a structured software verification process. 
  • Participates in new product development team design control meetings and design reviews.  Reviews and approves project software deliverables for compliance against applicable standards and internal protocols.
  • Provides guidance on software verification requirements to project teams.  Develops, conducts and executes verification plans for in-house developed software.  Writes technical reports for submission to regulatory agencies.
  • Assists in the development Standard Operating Procedures (SOPs) to support the Quality System in regards to software design and life cycle maintenance.  Monitors the effectiveness of the software development policies, procedures and standards and implements improvements as needed.
  • Maintains and administers the software issues tracking system.  Works with the software development teams to ensure software issues are properly characterized and handled appropriately.

 

Qualifications

  • Four year degree or equivalent optimal. Computer science or engineering degree preferred.
  • 8+ years experience with software verification in a regulated environment, preferably in the Medical Device Industry.   
  • Knowledge of software testing strategies, verification and validation procedures in a regulated environment per software development life cycle guidelines.
  • Experience with developing test protocols for either embedded, desktop or compute cluster platforms.  Automated verification tests preferred. 
  • Working knowledge in one or more of the following languages: C#, C++, Java, a scripting language such as Perl, or Matlab.
  • Working knowledge of external standards, including 21 CFR Part 11, Part 820, ISO 13485 and IEC 62304 optimal.
  • Previous experience with Class III implantables optimal.
  • Start up or small company experience preferred.

 

The Intangibles

  • Able to demonstrate a sophisticated level of engineering understanding and you work exceptionally well with multi-disciplinary teams including mechanical, electrical and software engineering teams.
  • Cognizant of business objectives when developing product quality and reliability improvements.
  • A person who has demonstrated a proven ability to sell concepts and build consensus among a diverse set of stakeholders.
  • Extremely well organized with strong analytical and problem solving skills.
  • A strong, effective communicator with great presentation and interpersonal skills.
  • A terrific project manager and have a proven record of consistently following through on commitments.
  • Excited about working with a small, early-stage medical device company.
  • Exceptionally team focused, self-motivating and passionate for innovation and quality.
  • The type of person who consistently demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all interactions both inside and outside your workplace.

 

Please send your cover letter and resume via email to: , with "SQE" in the subject line. This position is eligible for relocation assistance.

NeuroVista is proud to be an equal opportunity employer.

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