Senior Quality Engineer - Released Product

A career at Medtronic is like no other. We’re purposeful.

We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people. Help us engineer the extraordinary Bring the next generation of life-changing medical technology to patients worldwide.

We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description.

We are currently looking for a Senior Released Product Management Quality Engineer to join our Cranial and Spinal Technologies operating unit (CST). This position will be based onsite in Lafayette, Colorado. Part of the Neuroscience portfolio, Cranial and Spinal Technologies (CST) is redefining cranial and spinal procedures to reduce variability and improve outcomes with the goal of restoring long-term quality of life for more patients. CST is comprised of four global businesses:

Spine & Biologics, Enabling Technologies, intelligent Data Solutions (iDS), and China Cranial, Spinal, Orthopedics & Technologies. Spine & Biologics, offers procedural solutions for spine surgery, and bone grafting solutions for spinal fusion. Enabling Technologies, delivers an innovative portfolio which include robotics, navigation, intra-operative imaging, advanced energy devices, cerebral spinal fluid management and critical care.

Intelligent Data Solutions (iDS), with Medicrea as the foundation, is revolutionizing the standard of care for personalized spine surgery using data science and Artificial Intelligence (AI) so all spine surgeons can provide predictable and reproducible patient outcomes. China Cranial, Spinal, Orthopedics & Technologies, provides solutions in spine surgery, neurosurgery, surgical synergies, biologics, and orthopedics. A Day in the Life In this exciting role, you will represent the Design Quality Engineering team, working with cross-functional partners in defining the strategy and deliverables for medical device released product management (RPM) projects.

Responsibilities may include but are not limited to: Represent Design Quality Engineering in medical device lifecycle management by engaging with cross-functional partners in system and product continuous improvement projects.

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

Review risk management documents and conduct a change impact assessment with focus on product design for every change request that pertains to modifying released products. Review and approve mechanical drawings in accordance with ASTM-14.5Y. Perform statistical analysis of data generated including but not limited to:

Process capability, Cpk, Ppk, Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis against predetermined acceptance criteria. Technical problem solving, compiles data and prepares reports on findings, to identify trends, proposes corrective action as needed.\ Mentor junior quality engineers in providing quality engineering support for their medical device products Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and inhouse Standards.

Must Have: Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume. Bachelor’s Degree in Engineering, Science, or a technical field Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience Nice to Have Geometrical Dimensioning and Tolerancing (GD&T) experience and the ability to identify undefined features.

Experience in Risk Management activities in accordance with ISO14971 and applied statistical analysis for the determination of testing acceptance criteria. Experience leading and coordinating multiple quality engineers or contractors to achieve project deliverables. Statistical analysis experience:

Process capability, Cpk, Ppk, SPC, Gauge R&R, ANOVA, Sample Size determination and variable/attribute data analysis. Component qualification experience. Quality Certifications from ASQ:

CQE, CRE or CQA. Green Belt or Black Belt certification. 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. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Benefits & Compensation 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. 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). 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.