At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Careers That Change Lives
Principal Design Assurance Engineer, Systems Risk Integration

DIABETES
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
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. We’re 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 is 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.
In the function as a Principal Design Assurance Engineer, the candidate shall collaborate cross-functionally with team members from Systems Engineering, R&D/ Design, Manufacturing Operations, Pre & Post Market Quality, and Regulatory Affairs to ensure the successful execution of program objectives.
This individual shall ensure adequate support for all hardware design work products pertaining to design controls are met (e.g. Design Inputs & Design Outputs and documentation required through each designated design phase gates, including DV&V). The ideal candidate shall provide guidance to the program/business in interpreting and executing against the business unit’s quality system.
Meanwhile, the candidate shall function as the subject matter expert that leads risk management development activities & generating tailored risk documentation outputs across different components (Insulin Pumps, Continuous Glucose Monitors & algorithms) that make up an interoperable Automatic Insulin Delivery (AID) system. The candidate is expected to understand systems engineering principals to support AID system architecture development.

This position shall provide reviews of all engineering test plans/ reports in support of the interoperability system framework, ensuring appropriate requirement decomposition and traceability flow down to appropriate verification using the correct test methodologies.

A Day in the Life

This individual contributor role reports into the Pre-Market Hardware Design Assurance team.

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

• Coordinates decisions between quality and engineering counterparts.  Effectively navigates & facilitates project teams with respect to enterprise and BU’s processes and procedures to ensure the delivery of a safe and effective product design.

• Facilitation & execution of design & process risk management deliverables by facilitating and generating product design failure modes effects analysis (dFMEA) & Hazard Risk Analysis Documents (RAD)

• In addition to base knowledge of Quality Management Systems (QMS) under 21CFR 820 for class III medical devices, the familiarity of the following CFR sections for special controls for class ii medical devices: 21CFR862.1355 (iCGM), 21CFR880.5730 (ACE), 21CFR862.1356 (Algorithm).   

• Experience/ familiarity working with Class III Premarket Approval (PMA) and Class II 510(k) regulatory pathways

• Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

• Use of statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, GR&R etc., to inform design decision making and conclusions for deliverables like test method validations, process characterizations and verification, process validation and reliability demonstration activities

• Design Verification/Validation and Reliability demonstration – Understands and applies basic Design Verification/Validation methods & principles for developing design verification, validation, and reliability test strategies.  Participates and collaborates with test engineers in the development, modification and design review of Protocols, Data Summaries & Record. Support generation of master validation plans/reports and design transfer activities as applicable.

• Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and in-house Standards.

• Participation across multiple project teams in technical review & design review activities. Leads design change control evaluations and design impact assessments.

• Partnering with appropriate design and operations team members in early design and development to ensure essential design outputs / critical to quality (CTQ) attributes are traced to manufacturing process output specifications and controlled in manufacturing processes development activities.

• Understands the interdependencies of FDA design controls and production and process controls and ensure processes are developed with the right level of control and maturity to deliver products for design verification testing and design validation studies.

• Ensuring all applicable work products comply with Medtronic procedures, acceptable qualitative and quantitative criteria, and global standards and regulations.

• Ensures Product design can be appropriately integrated to system design.

• Participating in support of external and internal regulatory audits and inspections.

• Driving operating procedures / process improvement activities.

• Capable of mentoring junior quality engineers in providing quality engineering support for their medical device products. 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 operating unit (OU) strategies and products.

• Provide support to the Regulatory Department in writing technical submissions. 

Must Have: Minimum Requirements  

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelor’s degree in engineering or related Sciences with 7+ years of relevant quality engineering experience

Or

Master’s degree in engineering or related Sciences with 5+ years of relevant quality engineering experience

Nice to Have  

• Clear understanding of systems engineering principals consisting of any combination of the following: Hardware, Firmware, Software, Cloud database, Stand-alone Applications.

• Demonstrated ability to work with all levels of the organization    

• Communicate clearly, in written, verbal and visual forms, being equally facile with technical and nontechnical team members  

• Working knowledge of diabetes therapy, clinical data, business plans and competitive products 

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
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.
 

Salary ranges for U.S (excl. PR) locations (USD):$116,000.00 - $174,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.

At Medtronic, most positions are posted on our career site for 3-7 days.