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

Principal Hardware Design Assurance Engineer, Pre-Market Quality supporting diabetes products.

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 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.

As a Principal Hardware Design Assurance Engineer in the pre-market Quality organization, you shall serve as a subject matter expert by leading and providing quality engineering support for the design & development of new product development programs that spans from hardware design, electromechanical interface, systems engineering support, and process development. The ideal candidate will act as a subject matter expert and provide guidance to the program/business in interpreting and executing against the business unit’s quality system elements.

This individual shall ensure adequate support for all hardware design work products pertaining to design control are met (e.g. Design Inputs & Design Outputs and documentation required cradle the product design through each designated design phase gates alongside program management, including DV&V). Within the design control framework, the candidate shall lead efforts developing deliverables for risk management. Additional support for engineering outputs includes, but not limited to engineering test plans/ reports, requirement documentation & traceability, engineering test methods and test result review.

The candidate is expected to understand design transfer principals to support prototype manufacturing (pilot and scale-up) in collaboration with process development Subject Matter Experts assigned to the program. The candidate shall apply engineering support to ensure development of the manufacturing process meets the established requirements of the product design meanwhile complying to Medtronic’s quality, reliability requirements.

This individual is experienced in performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R).

This position will work across the organization driving and collaborating with functions in Design & Development, Operations, Quality and Regulatory to assure the successful execution of business goals.

A Day in the Life

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

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

• Facilitation & execution of design & process risk management deliverables by facilitating and generating product design failure modes effects analysis (dFMEA), Hazard Risk Analysis Documents (RAD), and associated deliverables like process failure mode effect analysis (pFMEA).

• Lead product design & development activities for a complex medical device product development program by effective utilization of dFMEA structure to identify key inputs, outputs, & related design controls.

• 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

• 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.

• Participates on project teams, technical review & design review activities. Leads design change control evaluations.

• Travel to vendor locations and manufacturing sites as needed to help ensure programs meeting deadlines and troubleshoot issues. Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering qualification activities.

• 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.

• Play a hands-on role in design transfer planning and ensure development projects are transitioned to manufacturing facilities – play a key role if defining success KPIs, design specifications to process output specification flow down, manufacturing process development & qualification for transitioning development projects to manufacturing across multiple Medtronic sites and quality systems.

• Apply methodologies such as Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA) and Cell Operating System (COS) during process design and development phase

• Collaborate with product and process development teams to develop P-diagram/ Input-Process- Output (IPO) matrices, process characterizations, test methods and process validation strategies (IQs/OQs/PQs and TMVs) for new products in development

• 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.

• 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.

• Collaborate with the various product development teams like R&D, Regulatory, Ops, Design / Supplier quality, & Post Market Quality functions, including but limited to: risk management, complaint trending, CAPA ect.

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

• Leading CAPA projects and assisting post market analysis associated with the assigned product line.

• 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.

• Performs other related duties as assigned.

Must Have Minimum Qualifications

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

• 5+ years experience with medical devices involving insulin delivery

• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive

• Proficiency is Spanish is a bonus.

• Travel is required, up to 30%

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 - $174,000.00This 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.