Careers that Change Lives

This position is an exciting and new opportunity that is currently part of Medtronic and will move to a to-be-named company we are calling “NewCo”. NewCo will be an independent company with equal partners, Medtronic & DaVita. It will be established in calendar 2023 as a new company (NewCo) formed from Medtronic’s Renal Care Solutions Operating Unit focused on providing innovative technologies to support kidney care patients. While you will start your employment with Medtronic, upon establishment of NewCo your employment will transfer to NewCo and you will no longer be employed by Medtronic.

NewCo is uniquely poised to transform renal care and dialysis, building on Medtronic’s innovation and technology pipeline. The business will have the singular focus, financial commitment, deep domain expertise, and global footprint needed to accelerate the development and commercialization of affordable and scalable life-saving renal care technologies — particularly our transformative home dialysis platform technologies.

A Day in the Life
NewCo is searching for a P rincipal SW Design Quality Engineer .

Provide Quality Engineering support and leadership to ensure the successful development of Medtronic Renal Care Solutions products. This individual will be expected to apply his/her knowledge of Design Control principles and quality engineering techniques to positively influence product development efforts. In parallel, the candidate shall also ensure the products are developed and manufactured in accordance with applicable company policy, industry standards, and regulatory requirements

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

• Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
• Knowledge of Design History File in accordance with 13485/FDA 21 CFR 820
• Collaborates with engineering functions to ensure quality standards are in place.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
• Reviews include applicable specifications, materials, tools, techniques, and methodologies. - Provides or directs verification and validation of software system requirements, traceability, and testability
• 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.
• Accompanying documents review due to SW updates
• Provide guidance to Engineering staff and other personnel and ensures that Design Control requirements are being met in an effective manner, including Design Input/Output, Design Verification/Validation, Risk Management, Test Method Validation and Component Qualification
• Reviews master test plans that encompass Design Verification/Validation, and Test Method Validation activities.
• Contributes to requirements activities and requirements impact analysis
• Promotes a continuous improvement culture in Design Control activities and proactive utilization of quality tools with design team.
• Maintains knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.
• Travel requirement: Less than 10%

Must Have

To be considered for this role, the following minimum requirements must evident on your resume.

• Bachelors Degree in Engineering, Science or Technical Field with 7+ years of experience in Engineering, Software Development and/or Quality OR Advanced Degree Engineering, Science or Technical Field with 5+ years of experience in Engineering, Software Development and/or Quality
• Working knowledge of software development for medical devices (IEC 62304)
• Good oral/ written communication skills and interpersonal skills.
• Ability to work in a cross-functional team
• Ability to work in an international team
• Good written, speaking and listening skills in English
• Working knowledge of quality systems and quality assurance processes and principles, with a focus on software development and verification/validation activities (IEC 62304) and risk management activities (ISO 14971)
• Good knowledge of risk management (generation of system risk analysis, DFMEA, SW DFMEA)
• Working knowledge of bringing software products or apps from ideation to market
  

Nice to Have:

• Experience working in a medical device industry (e.g., FDA-regulated, ISO 13485)
• Working knowledge with software, such as C, C++, Python
• Submission of products in FDA and/or CFDA’
• Experience in assuring Cybersecurity for Medical Devices’
• Experience with statistical techniques (e.g. DOE, ANOVA)
• Knowledge of SW configuration management tools (e.g. SVN, GIT)
• Knowledge of ticket/defects management tools (e.g. Jira)
• Management of non-conformities
• Prior experience in the Medical Device industry in design and development of Medical Devices.
• Prior experience in the Medical Device industry in validation activities of test method applicable to Medical Devices.
• Experience with active dialysis devices
• Green belt certification
• Problem Solving Technique
• MDSAP audience experience (front room as SME)
  

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)