Principal - Quality Engineer

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

Summary

The Principal Supplier /Manufacturing Quality Engineer is responsible for :

• D riving exceptional component quality through his/her expertise in supplier selection strategy, supplier management , component qualification s .

• Support ing Medtronic i nternal a ssembly/ m anufacturing process qualification and validation .

This role assists new product development teams and suppliers in providing components that consistently meet specifications, quality and reliability, delivery, and cost requirements . Success requires broad knowledge of new product development and manufacturing methodologies, design control systems and quality management practices.

Primary Responsibilities

• Conducts supplier selection , assessments, quality system audits and supplier part and process qualification (PPAP) .

• Responsible for the component qualification process, FAI, and manufacturability assessment.

• Lead design for manufacturability and assembly (DFMA) discussion with Medtronic design team and supply base.

• Assures supplier compliance to relevant quality and regulatory standards.

• Provides feedback to design teams regarding suppliers' capabilities, tolerance, specifications, measurement, and test methodologies.

• Is a liaison between NPD teams and suppliers on technical and/ or quality issues .

• Works directly with suppliers to achieve goals including some travel on short notice.

• Assures Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the Supplier CAPA ( SCA PA) process.

• Co-lead with R&D Manufacturing Engineer s on Process Failure Mode and Effect Analysis (PFMEA) , developing Process Control Plans (PCP) and Process Validations (IQ/OQ/PQ).

• Is informed about advancement in area of expertise and is knowledgeable about new rules, regulations, and standards.

Required Skills and Knowledge

• New Product Development Processes

• Ability to work with a supplier on requirements, specifications, process improvements, and capability studies.

• Background in Six-Sigma, LEAN, FTQ, DFSS and related quality management tools

• Familiar with ISO 9001 or ISO 13485/820 requirements

• Ability to resolve complex problems requiring detailed data analysis, calculation, or experimentation.

• Expertise/experience in Injection Molding, Machining, Die Cast, Stamping, Extrusion, MIM, etc

• Technical abilities in understanding the interaction with comp onents and assembly ( e.g. tolerance analysis, fit and finish , functionality, etc.).

• Ability to determine which measurement instrument to use in various situations based on considerations such as the characteristic to be measured, the required accuracy level, and uncertainty.

• Proficiency in Minitab or JMP and working knowledge in statistics ( e.g. MSA, Normality , Capability, Hypothesis Testing, DOE, etc.).

• Effective verbal and written communication

Qualifications

• Bachelor's degree in Mechanical Engineering , or related field + 6 years' experience or Advanced Degree + 4 years' experience .

• Experience in Production Part Approval Process (PPAP ) , Process Validations , Design for Manufacturability and Assembly (DFMA), Proce ss Failure Mode and Effect Analysis (PFMEA) .

• Medical Device hardware/software/disposables experience is preferred.

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.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.