Sr. Principal Software Engineer - Newton, MA

Careers that Change Lives
Medtronic aims to contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. In order to recognize the personal worth of all employees, Medtronic provides an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. If you consider joining the team and you are committed to do meaningful work, make a difference, and improve lives, you will find a culture of collaboration and innovation at Medtronic. Starting the road to your rewarding career with them will come with competitive pay, bonuses, and benefits supporting your work-life balance.

In the role of Senior Principal Software Systems Architect for the Affera Mapping and Ablation System, you will join a growing software engineering team to drive commercialization and further product development of a next generation system used to treat cardiac arrhythmia in cardiac ablation procedures.

The Affera Mapping System comprises 3D visualization software used for mapping of electrical activity in the heart, navigation of catheters within the heart chambers, streaming intra cardiac and surface lead electrograms and annotation of 3D and 2D data points. The Mapping System integrates with the Affera Ablation System to record ablation telemetry and annotate in 3D regions where energy delivery was applied.

A Day in the Life

As a Senior Principal Software Systems Architect at Affera you will provide a technical leadership role in an outstanding engineering team, based in Newton, MA. The team is passionate about building a next generation software product line to help transform Medtronic’s Cardiac Ablation business. Joining a small but growing team, this role requires a broad range of skills, outlined below. The candidate should be comfortable with a highly collaborative fast paced work environment and be able to respond to changing needs, successfully advancing in several different work streams ranging from commercial release maintenance to pre clinical work, investigational work or prototyping.

Responsibilities Include:

• Deliver strategic technical leadership, participate in architectural decision making, applying domain expertise in software engineering best practices.
• Collaborate with other team leaders within the Affera group and division wide to ensure dependencies relating to hardware changes, or integration with other projects are identified and resolved.
• Support the software development life cycle, assisting with change management to ensure that upstream design documentation and associated traceability is maintained through each software release.
• Liaise with field support activities relating to rolling out of software updates to commercial sites, and complaint handling. In collaboration with Medtronic product security resources manage as needed periodic security testing with external contractors, maintaining the cybersecurity documentation stack including risk assessments. Drive security best practices within the software team.
• Participate in the hiring process, writing job descriptions, conducting phone and on-site interviews.
• Participate in internal and external audits to demonstrate regulatory compliance. Lead remediation activities where needed.
• Maintain software development plans and procedures, adjusting where applicable to changing internal practices or changing regulatory guidelines.

• Bachelor’s degree
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.

• Master's degree in Computer Science, Computer Engineering, Software Engineering
• Expert level knowledge of Python and modern C++
• Proven track record of software development and management in the medical device industry
• Extensive knowledge of ISO 62304 with experience of internal and external audits
• Knowledge of up-to-date FDA guidelines for software development and cybersecurity
• Experience with the post-market phase of a software product including activities such as complaint handling, field upgrades, defect triage.
• Experience with cybersecurity testing and post-market surveillance
• Experience delivering technical leadership to software teams experiencing rapid growth from a few engineers to 20 or more
• Regulatory strategy experience
• Audit experience