Quality Software Engineer II (Medical Device)

WHO ARE WE?

Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body.  Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure.   These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs.  With our recent PMA approval from the FDA, and acquisition by Edwards Lifesciences, we are growing our team – it’s a great time to join Endotronix!

WHAT YOU’LL DO

The Software Quality Engineer understands software quality development and implementation, software inspection, testing, verification, and validation, and implements software development and maintenance processes and methods. This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the product lifecycle. Develop and conduct training of company personnel for the software development and validation program. Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.

• Develop a thorough understanding of the entire software lifecycle for Endotronix product
• Provide quality engineering input to establishment of product specifications, quality plans, and software development/deployment procedures which consider risk management
• Review and approval of design verification and validation protocols and reports to ensure that test article selection, sampling rationales and test methodologies are technically sound and sufficient given level of risk and internal/external requirements.
• Review risk analyses and design and usability FMEAs for adherence to requirements
• Participate in design reviews to ensure customer and regulatory requirements have been properly translated in to design inputs which are complete, unambiguous and do not conflict.
• Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.
• Support software development and test process optimization to encourage reproducible quality outcomes
• Perform root cause analysis of field and internal issues and implement corrective actions.
• Support suppliers and internal investigations on quality related issues.
• Model a culture of quality within the company and guide employees in best quality practices.
• Design, implement, debug, and document test cases and scripts to ensure that software meets the business needs, while in compliance with applicable regulations and processes.
• Update and optimize quality assurance software development procedures. 
• Collaborate with other team members and product owners, both inside and outside of the team.
• Support the design and execution of tests using automated test tools, as well as manual test development process, for the verification of software requirements.
• Support test infrastructure set up and test tool development, such as test tools, , Hardware/Firmware simulators and emulators.
• Assist development team on debugging and solving issues discovered during test.
• Review project/product documentation
• Work closely with developers and Systems Engineers to understand the specifics of the Application, Mobile device & operating platform on which the Application would run and due considerations
• Work across teams to ensure all deployment processes are documented, repeatable, and stable
• Support automated software builds, tests, and deployments
• Complete tasks and projects in a timely manner to meet software release schedule
• Support and review software validation protocols traceable to system/software requirements.
• Assist in the completion and maintenance of risk analysis, focused on software related risks.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving issues.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

WHAT YOU BRING TO THE TABLE

• 2+ Years Software Quality Engineering experience.
• Detailed knowledge of FDA, 21CFR820, IEC 62304 and ISO 13485.
• Prior medical device experience preferred. ASQ CSQE certification desired.
• Proficiency with IEC 62304 standards and FDA software development and pre/post market cybersecurity guidance documents
• Proficiency with software validation tools for product software/firmware, production software/firmware, OTS software, QMS software and spreadsheets.
• Proficiency with waterfall software development, incremental/iterative and Agile software development life cycles 
• Proficiency with software configuration change management and bidirectional traceability
• Advanced computer skills, including statistical/data analysis and report writing.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Builds productive internal and external working relationships to resolve mutual challenges 
• Exercises judgment within defined procedures and practices to determine appropriate actions.
• Determines a course of action based on guidelines and modifies processes and methods as required
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Strong organizational and follow-up skills, as well as attention to detail.

EDUCATION

WHAT WE’RE LIKE

• Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward. 
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results. 
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness. 
• Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results. 
• Entrepreneurial, flexible, yet results focused. 
• High degree of intellectual curiosity, honesty, and capability. 
• Low ego and humble in spirit in spite of your track record of outstanding performance. 

LIFE AT ENDOTRONIX

• Our shared company values create a foundation of trust and collaboration.  United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians.  And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
• We provide a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment that will help you to thrive and succeed in your career.
• Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability.  We are passionately committed to building a diverse organization where all perspectives and cultures are celebrated.