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Medtronic Sr. Software Engineering Manager - Medical Device Commercialization (Newton, MA) in Newton, Massachusetts

Sr. Software Engineering Manager - Commercialization

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 a 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 Software Manager of Commercialization for the Affera™ Mapping and Ablation System, you will lead and grow a 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™ Prism-1 Mapping Software is a 3D visualization software used for mapping of electrical activity in the heart, navigating catheters within the heart chambers, streaming intra cardiac and surface lead electrograms and annotating 3D and 2D data points. The Mapping Software and system as a whole integrates with the Affera™ Ablation System to record ablation telemetry and annotate in 3D regions where energy delivery is applied.

A Day in the Life

As Senior Software Manager of Commercialization you will build, lead, and grow 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 commercial release maintenance and new feature deployment across multiple software products and markets.

Responsibilities Include:

· Build a new engineering team to meet business that adequately support commercialization activities.

· Plan and execute revisions to commercially released software including several distinct software products and multiple regulatory markets.

· Oversee activities relating to roll out of software updates to commercial sites.

· Support the complaint handling process, triaging defects and feeding back into the project plan as needed.

· Collaborate with other team leaders within the R&D group and division wide to ensure dependencies relating to hardware changes, or integration with other projects are identified and resolved.

· Drive cybersecurity best practices within the software team.

· As team grows:

o Oversee career development of team members, including setting goals, conducting quarterly and annual reviews and compensation adjustments.

o Lead daily meetings to review tasks, address blockers and ensure that all team members are working together to achieve the short term goals, following agile software development best practices.

· Release planning

o Ensure the integrity of issue tracking across multiple products and distributions.

o During V&V activities participate in test planning, and regression analysis, reviewing software changes to ensure that selected testing is appropriate.

o Deliver end to end high quality software releases and associated documentation.

· Regulatory

o Participate in internal and external audits to demonstrate regulatory compliance. Lead remediation activities where needed.

o Maintain software development plans and procedures, adjusting where applicable to changing internal practices or changing regulatory guidelines.

Must Have: Minimum Requirements


· Bachelor’s degree in Computer Science , Computer Engineering, Software Engineering or equivalent technical discipline

· Minimum of 6 years of technical experience with 3+ years of managerial experience

· 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

Nice to Have

· Masters degree in Computer Science, Computer Engineering, Software Engineering

· Experience with the commercial phase of a software product including activities such as complaint handling, field upgrades, defect triage.

· Experience with cybersecurity penetration testing

· Experience growing a software team from a few engineers to 20 or more, or experience working in a team during such a growth period.

· Regulatory strategy experience

· Audit experience

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here ( .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.