Senior Principal Quality Engineer

We anticipate the application window for this opening will close on - 5 Sep 2025At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.# **A Day in the Life****Careers that Change Lives**A career at Medtronic is like no other. Were committed to and driven by our mission to alleviate pain, restore health, and extend life for millions of people worldwide!Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.**A Day in the Life**Medtronic is currently searching for a**Sr.** **Principal Quality Engineer**to join the New Product Development team at the Lafayette, CO facility. Youll play a crucial role in supporting our Surgical business unit by ensuring that our suppliers deliver high-quality parts, materials and service. You will also participate in design transfer and manufacturing quality activities.**Key Responsibilities:*** Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.* Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.* Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred.* Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits.* Evaluate suppliers' internal functions to assess overall performance and provide feedback.* Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization).* Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting.* Manage the Approved Supplier List, including administrative work in MAP Agile.* Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.* Improve suppliers' performance and reduce escapes to manufacturing.* Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development.* Knowledgeable in Statistical analysis (MSA, Capability, SPC)* Support DFMEA and PFMEA activities* Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team* Design Transfer; translating design specifications into production specifications.* Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.* Provide mentorship and coaching.* The job requires occasional travel to visit suppliers within the United States and internationally.**Must Have: Minimum Requirements*****To be considered for this role, please ensure the minimum requirements are evident on your resume.**** Bachelors degree in engineering or related field* Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years relevant experience**Nice to Have:*** Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred* Medical device manufacturing industry experience, preferably ISO 13485.* Lead auditor experience.* Hands-on experience with SAP, Trackwise, Agile change management.* Ability to manage tasks and projects under tight deadlines with a sense of urgency.* Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership.* Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization.* Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments.* Engage in changes and advocate for inclusion/diversity.* Experience with materials and manufacturing processes such as PCBAs, MIM, nitinol, cables, crimping, laser welding, automated functional testing* DRM or DFSS* Knowledge of GD&T**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. Lets 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, recruiter, or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).**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):$147,200.00 - $220,800.00This 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).The following benefits and additional compensation are available to those regular employees who work #J-18808-Ljbffr