Lead Software Quality Engineer

We are working with a fast-paced medical device start-up developing break through solutions for the diagnosis and treatment of cardiovascular disease. 

Using breakthrough optical imaging technology along with advanced machine learning algorithms, our client company provides life saving insight during cardiac procedures.

This position is On Site  west of Boston vic.  Watertown, Waltham, Arlington, MA

Job Summary

Our client is seeking a Lead - Senior - Principal, Software Quality Engineer to join a talented team and provide software quality assurance leadership and support for medical device development. 

In this role, you will facilitate the application of design controls, risk management and usability, with a focus on software, for complex electromechanical medical devices that include sterile, single-use disposables.

A successful track record of hands-on experience and leadership with the development and implementation of processes to design, assess, and monitor product development is a must have.

In addition, this individual will help develop, establish, and maintain quality methodologies, systems, and practices to facilitate software product development, and related functions to meet company requirements.

This position reports to the VP of QA/RA and is a critical member of the product development team.

Key responsibilities

• Develop, implement and maintain procedures to guide software and systems development 
• Lead software development compliance and validation activities, including:  Risk Management for Software Design, Software Verification, Systems Validation, Traceability
• Provide software design assurance support and leadership in the design and development of the company's products and systems.
  
• Define or identify potential compliance gaps and assess new regulations against existing or new software and computer systems.
• Track and risk assess software Anomalies for pre- and post-market medical device software.
• Participate in cybersecurity and other risk management processes (DFMEA, PFMEA, SHA). 
• Author and execute software test protocols and generate test reports.
  
• Support internal and external regulatory audits, and other quality assurance functions.

Required Qualifications

• Bachelors in Computer Science, Electrical Engineering or equivalent technical discipline
• Minimum 5 years of experience within software quality role with strong experience with complex medical systems containing software and hardware
• Knowledge and experience with SDLC processes along with software development methodologies
• Prior experience with overseeing software bug tracking, or experience managing tools like JIRA.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IEC 62304.
• Strong knowledge of risk management standard ISO 14971.
• Experience supporting regulatory submissions for both clinical and commercial uses, such as IDE, 510(k), or PMA.

Preferred Qualifications

• ASQ Certified Software Quality Engineer (CSQE).
• Cyber Security experience.
• Design and implementation of automated software testing tools and platforms - Squish, Silk-Test, Etc.
• Strong understanding and hands-on knowledge of software best practices (C#, continuous integration, automation, test driven development, UX and HF, etc.)
• Ability to interpret software design and code to verify implementation of requirements.