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Software Engineering Program Manager Quality Core Team Member

Medtronic
Los Angeles, CA 90006 Work Remotely
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Software Engineering Program Manager Quality Core Team Member

Location:

California, United States

Requisition #:

21000ISD

Post Date:

Oct 21, 2021


**SoftwareEngineering Program Manager Quality Core Team Member** **(Pump Software)**

**21000ISD**

**Northridge, CA or Remote West Coast USA**


**Careers That Change Lives**


In this exciting role as a Software Engineering Program Manager Quality Core Team Member (Pump Software) you will have responsibility for being the focal point of Quality forinsulin pump software developmentprogramsin the Diabetes business. You will be a core team member leading and representing the Quality function to reach the highest level of quality and clinical outcomes for these products. These products are the key vehicles that the Diabetes business uses to deliver on the Medtronic mission to alleviate pain, restore health, and extend life. This role will plan the quality deliverables, resources, DRM approach and be the voice of quality throughout the development lifecycle.


**Diabetes**


The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. Were committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.


Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Serves as a primary focal point and contact for all quality aspects of a project. Represents and make decisions on behalf of quality on the core team.

+ Maintains alignment and manages execution across all Global Quality disciplines.

+ Collaborate with RD, system engineering, our product management organization and partnerengineering teams in making product design decisions.

+ Collaborate and develop FMEA and System Hazard Analysis tohelp drive good designs at early development stages.

+ Understands real-world and clinical diabetes solutions and navigates and uses data from continuous glucose monitoring systems and insulin pumps.

+ Lead and mentor our software engineering group to achieve strong organizational performance, grow and manage individual talent, and advance our technology strategy.

+ Drives establishment of Quality, Reliability, and product development strategies to improve safety, reliability, and usability of the product family for our patients.

+ Drive product delivery across multiple programs and oversee results of remote teams who must work closely and collaboratively with your US-based engineers.

+ Provide leadership and guidance to create consistency in our architecture, interface, and designs that will enable platforms and future product expansion.

+ Driving establishment of test strategies for complex systems, partnering with regulatory on strategies for emerging technology.

+ Ensuring that design issues found are being adequately addressed by the appropriate stakeholders for that issue through technical reviews, or through design reviews if those are more appropriate.

+ Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.

+ Understanding and anticipating core team needs in terms of resources and timelines, aligning with functional managers and quality core team members to deploy appropriate resources to a program.

+ Grow process maturity and establish quality metrics in conjunction with RD management to meet customer expectations, reliability, and system performance.

+ Analyze, diagnose, and resolve customer problem reports, working closely with product support.

+ Establish software lifecycle metrics that provide management by data for multiple projects running in parallel.

+ Communicate key program information to Core Team Quality Leadership to ensure engagement and alignment, including exceptions, roadblocks, key decisions related to design trade-offs, risk-benefit and performance to key metrics and compliance. Build a culture of quality and engineering rigors spanning the software engineering life cycle.

+ Participate and support external regulatory audits and inspections.

+ Review software code and participate in detailed technical design and code reviews.


Responsibilities may also include the following and other duties may be assigned.


+ Plans, directs and implements all aspects of the companys design and development of new medical device products or software systems.

+ May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

+ Oversees the investigation and evaluation of existing technologies.

+ Guides the conceptualization of new methodologies, materials, machines, processes or products.

+ Directs the development of new concepts from initial design to market release.

+ Manages feasibility studies of the design to determine if capable of functioning as intended.

+ Monitors documentation maintenance throughout all phases of research and development.

+ Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.

+ Selects, develops and evaluates personnel to ensure the efficient operation of the function.


**Must Have: Minimum Requirements**

**To be considered for this role, please ensure the minimum requirements are evident on your resume.**


Bachelors Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering, Quality,Software Development, Program Management and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality,Software Development, Program Management and/or experience in a regulated industry


**Nice to Have**


+ Degree in Computer Science or Biomedical Engineering strongly preferred.

+ Extensive experience in embedded software development and integration

+ Hands on experience in environments applying modern engineering practices (Lean, Agile).

+ Experience in software test design development and review, and in reviewing and executing embedded software verification.

+ Experience in performing embedded software requirements analysis, architecture design and detailed design activities.

+ Experience in software processes and best practices for complex teams a plus

+ Experience in medical device industry.

+ Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, and MDD/EU MDR.

+ Demonstrated success in project management, with exceptional influence management skills

+ Strong written and verbal communication skills

+ Strong competencies in judgement and problem solving (especially root cause analysis)

+ Proficient in spreadsheets and project management tools

+ Working knowledge of multiple quality disciplines, especially reliability, safety and compliance

+ Experienced practitioner of Design for Reliability and Manufacturability (DRM)

+ Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations.


**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)


Travel up to 25%
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.

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Posted: 2021-09-14 Expires: 2021-12-10
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Medtronic
Los Angeles, CA 90006

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