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Manager, Software Engineering Sustaining

Carlsbad, CA 92008
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Manager, Software Engineering Sustaining


Carlsbad, California, United States

Requisition #:


Post Date:

Feb 18, 2021

**Careers that Change Lives**

Medtronic is a global leader in medical technology, services, and solutions that take on the healthcare industrys greatest

challenges. You will be a member of Respiratory Medical Services in Minimally Invasive Therapies business group that

supports design and development of ventilation products that save patient lives and impact patient outcomes. Come for a

job, stay for a career.

**A Day in the Life**

The Sustaining Software Managers primary responsibility is to lead a global team of engineers who develop, test and

deploy software in the support of Medtronics commercialized Ventilation products.

**Summary of Position**

The Sustaining Software Manager will have successful experience in software development with proven ability to lead a

team of highly skilled internal and external software and algorithm engineers in the planning, development, prototyping,

documentation, test and qualification of software and firmware for innovative and high-performance medical devices.

In addition to establishing and maintaining the technical competency of the team, this position requires coordination and

collaboration of activities with other RD Managers and cross functions.

+ The candidate will lead a team that is responsible for design history files, determining test requirements and coordinating

+ and executing verification and validation testing. In addition to implementing design changes that either enhance

+ performance or address quality issues, the team will support or lead complaint investigations, determines root cause

+ failure modes and provide solutions for these issues.

+ The candidate must have a proven track record of implementing change in a dynamic, fast-moving environment.

+ This position will be responsible for providing and ensuring consistent project planning, technical development plans,

+ FMEA and Risk Management, and design rigor throughout all projects that is consistent with and in accordance with FDA/

+ QSR for Medical Devices. Solid understanding of software development life cycle models and IEC 62304 principles

+ The Sustaining Software Manager will represent the design team in certification and regulatory audits.

**Responsibilities Include:**

+ Manage a team of technical personnel who provide support for the range of existing Ventilation products.

+ Identify and scope the required work. Organize and build detailed plans including schedules, resource budgets, qualityand risk management plans, and verification and validation plans. Organize timely response to urgent situations.

+ Responsible for software configuration strategy, deployment and support. Establish operational objectives and providetechnical direction and leadership

+ Participate in system level design analyses, ensure consistency in design reviews, verification and validation efforts

+ Manage team and project communications, reporting and staffing. Ensure that the proper inputs are received and that theproper personnel/departments are involved in project decision making.

+ Coordinate with the global, cross functional business team at the design sites, manufacturing sites, service centers, prioritize and execute projects and resolve issues. International travel is required.

+ Manage the execution of the assigned projects. Prioritize and direct work. Work closely with project managers to ensureall project activities and deliverables are completed in a timely manner.

+ Provide technical leadership in solving engineering problems and fostering creativity and innovation in design and problem solutions.

+ Ensure design practices, test methodologies, and documentation meets the requirements of internal policies and externalregulations. Adhere strictly to policies and procedures associated with an FDA controlled environment.

+ Accountable for the technical completeness of the teams output.

+ Accountable for compliance with Design Control and Medical Device standards, such as FDA QSRs, ISO, IEC etc.

+ Active assessment of individuals and the teams needs and gaps. Establish and execute plans for the development ofeach individual and the team as a whole.

**Must Have: Minimum Requirements**

+ Bachelors degree required

+ Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

**Nice to Have**

+ BS or MS in Computer Science or Electrical Engineering with focus on Software.

+ A minimum of 10 years in the design and development of software engineering solutions.

+ Minimum of 3 years functional management experience.

+ Medical device industry experience is required.

+ Competent in software development processes including design methodologies, source code management, build

+ management, quality process, requirements-driven development, and the defect tracking and resolution process.

+ Experience managing software engineers and technical staff

+ Experience with internal and outsourced projects

+ Proven ability to partner cross functionally to successfully drive the business

+ Demonstrated relationship building skills and ability to influence without direct authority

+ Solid working knowledge of quality and regulatory requirements for medical devices, plus experience dealing with

+ regulatory agencies or outside professional groups (e.g. FDA, ISO, ANSI, HIMA)

+ Strong communication skills, cross functionally, across all levels of the organization

+ Effective multi-tasker and problem solver with a high energy level and strong organizational abilities. Attention to details, ability to think strategically and tactically.

+ Prioritization, Project Management and Team Building

**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. Lets 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)
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.


Posted: 2021-02-23 Expires: 2021-05-02
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Manager, Software Engineering Sustaining

Carlsbad, CA 92008

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