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Principal Software Design Assurance Quality Engineer

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Engineering
📅
19000J18 Requisition #
Careers That Change Lives
   

In this exciting role as a Principal Software Design Assurance Quality Engineer, you will serve as a subject matter expert by leading and providing technical design quality support for the new product development and sustaining projects. The individual will act as a subject matter expert and provide guidance to the business in interpreting and executing against Medtronic quality system elements including software/system work products to ensure compliance. This individual will ensure that all system-level project / program work products (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet Medtronic’s quality, reliability, and compliance requirements. This individual will ensure Design Quality Assurance-driven initiatives meet objectives in delivering highest quality products, with supporting tools and processes.

 

 

 

DIABETES

 

 

 

Transforming diabetes care together, for greater freedom and better health.

 

 

 

Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.

 

 
NON-INTENSIVE DIABETES THERAPIES play a prominent role in our strategy to transform our business into a holistic diabetes management company. As we look to support patients across the disease continuum, it is critical for us to continue expanding our reach to type 2 patients in need of better diagnostic and monitoring solutions to manage their glucose levels.
 

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

 

 

 

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

 
 

 

A Day in the Life 

 
  • Leading large and complex medical device product development per the FDA design controls starting from design planning through design transfer.
  • Collaborating with project / program teams to ensure work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards, regulations, and guidance.
  • Working very closely with the development teams during early development of requirements & design (algorithm development and code) and providing feedback to the design based upon SFMEA/Hazard Analysis.
  • Ability to read software code and participate in detailed technical design and code reviews.
  • Understanding of the interdependencies of program work products and guide the teams in execution strategy and participating in development, review and approval of all program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports). 
  • Generating and driving risk management deliverables like SFMEA and Hazard Analysis and preferably experienced in facilitation / execution of the SFMEAs.
  • Chair cross-functional change control boards.
  • Utilizes knowledge of various Software Development Lifecycles (SDLC).
  • Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulations in support of the deployment of the different BU strategies and products.
  • Driving clarity and consistency in documentation.
  • Leading CAPA projects and assisting post market analysis.
  • Participating in support of external regulatory audits and inspections.
  • Driving Process improvement activities.
  • Work under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated.  Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.

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

  • Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
  • Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Defines appropriate measures to ensure product quality.
  • Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
  • Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
  • Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
  • Reviews include applicable specifications, materials, tools, techniques, and methodologies.
  • Provides or directs verification and validation of software system requirements, traceability, and testability.
 

Must Have: Minimum Requirements

 
  • Bachelor’s Degree in Engineering, Science or Technical field with 7+ years of work experience in Quality, Engineering and/or Software Development OR Advanced Degree in Engineering, Science or Technical field with 5+ years of work experience in Quality, Engineering and/or Software Development.

Nice to Have (Preferred Qualifications)  

 

  • Master’s Degree in Engineering, Quality, Regulatory, or related.
  • Experience working in a regulated industry (e.g. FDA -regulated).
  • Working knowledge of embedded and mobile application development for medical devices.
  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
  • Ability to author technical reports, business correspondence and standard operating procedures.
  • Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
  • Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
  • Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
  • Self-Starter with a sharp focus on quality and customer 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)

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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