<p>We anticipate the application window for this opening will close on - 26 Sep 2025</p> <p>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.</p> <p>A Day in the Life</p> <p>A Day in the Life</p> <p>Medtronic is currently searching for a Principal Quality Engineer to join the New Product Development team at the Lafayette, CO facility. You'll 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.</p> <p>Key Responsibilities:</p> <ul> <li>Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services. </li><li>Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems. </li><li>Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred. </li><li>Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits. </li><li>Evaluate suppliers' internal functions to assess overall performance and provide feedback. </li><li>Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization). </li><li>Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting. </li><li>Manage the Approved Supplier List, including administrative work in MAP Agile. </li><li>Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management. </li><li>Improve suppliers' performance and reduce escapes to manufacturing. </li><li>Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development. </li><li>Knowledgeable in Statistical analysis (MSA, Capability, SPC) </li><li>Support DFMEA and PFMEA activities </li><li>Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team </li><li>Design Transfer; translating design specifications into production specifications. </li><li>Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation. </li><li>Provide mentorship and coaching. </li><li>The job requires occasional travel to visit suppliers within the United States and internationally. </li></ul> <p>Must Have: Minimum Requirements</p> <p>To be considered for this role, please ensure the minimum requirements are evident on your resume.</p> <ul> <li>Bachelor's degree in engineering or related field </li><li>Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience </li></ul> <p>Nice to Have:</p> <ul> <li>Experience with pcba suppliers and validation of pcba test and manufacturing processes strongly preferred </li><li>Medical device manufacturing industry experience, preferably ISO 13485. </li><li>Lead auditor experience. </li><li>Hands-on experience with SAP, Trackwise, Agile change management. </li><li>Ability to manage tasks and projects under tight deadlines with a sense of urgency. </li><li>Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership. </li><li>Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization. </li><li>Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments. </li><li>Engage in changes and advocate for inclusion/diversity. </li><li>Experience with materials and manufacturing processes such as PCBAs, MIM, nitinol, cables, crimping, laser welding, automated functional testing </li><li>DRM or DFSS </li><li>Knowledge of GD&T </li></ul> <p>About Medtronic</p> <p>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.</p> <p>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.</p> <p>Physical Job Requirements</p> <p>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).</p> <p>Responsibilities may include the following and other duties may be assigned.</p> <ul> <li>Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. </li><li>Collaborates with engineering and manufacturing functions to ensure quality standards are in place. </li><li>Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. </li><li>Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. </li><li>Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. </li><li>May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. </li></ul> <p>TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.</p> <p>DIFFERENTIATING FACTORS</p> <p>Autonomy: Recognized expert, managing large projects or processes.</p> <p>Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.</p> <p>Coaches, reviews and delegates work to lower level specialists.</p> <p>Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.</p> <p>May manage large projects or processes that span outside of immediate job area.</p> <p>Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.</p> <p>Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.</p> <p>Implements solutions to problems.</p> <p>Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.</p> <p>May negotiate with others to reach understanding or agreement, and influence decision-making.</p> <p>Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.</p> <p>Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.</p> <p>Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.</p> <p>May have broad knowledge of project management.</p> <p>Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.</p> <p>Physical Job Requirements</p> <p>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.</p> <p>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.</p> <p>Benefits & Compensation</p> <p>Medtronic offers a competitive Salary and flexible Benefits Package</p> <p>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.</p> <p>Salary ranges for U.S (excl. PR) locations (USD):$119,200.00 - $178,800.00</p> <p>This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).</p> <p>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)</p> <p>The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).</p> <p>The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).</p> <p>Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.</p> <p>Further details are available at the link below:</p> <p>Medtronic benefits and compensation plans</p> <p>About Medtronic</p> <p>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.</p> <p>Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.</p> <p>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.</p> <p>Learn more about our business, mission, and our commitment to diversity here.</p> <p>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.</p> <p>If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.</p>