Senior Quality Engineer
MedtronicAbout the role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
The Peripheral Vascular Health (PVH) Operating Unit brings together a broad portfolio of peripheral vascular technologies, products, and services to address the needs of clinicians and patients worldwide. This organization partners across engineering, manufacturing, quality, and operations functions to support product performance, process excellence, and continuous improvement throughout the product lifecycle.This position is based at the Plymouth Nathan Lane facility in Plymouth, Minnesota and supports sustaining and project quality engineering initiatives across manufacturing operations. This is an onsite role with limited travel requirements.
As a Senior Quality Engineer, you will serve as the quality representative for sustaining and strategic manufacturing projects supporting the Peripheral Vascular Health business. This role partners closely with cross-functional stakeholders to drive process improvements, support manufacturing excellence, ensure compliance, and provide technical leadership for quality-related project activities.
Primary Responsibilities
Represent Quality Engineering on manufacturing and operational improvement projects, ensuring quality requirements are integrated into project planning and execution.
Partner with cross-functional teams to support capacity expansion, equipment replacement, technology implementation, yield improvement, and lean transformation initiatives.
Analyze manufacturing and quality data using statistical and problem-solving methodologies to identify root causes and implement corrective actions.
Develop and execute quality engineering deliverables, including risk assessments, qualifications, validations, and technical documentation.
Review and approve process changes, product dispositions, corrective and preventive actions (CAPA), and other quality system documentation.
Ensure manufacturing processes and quality activities comply with applicable regulatory, quality system, and internal requirements.
Generate and implement solutions that improve product quality, process performance, safety, yield, cost, and cycle time.
Provide technical guidance and mentorship to engineering and operations partners on quality engineering principles and applications.
Required Qualifications
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline and a minimum of 4 years of relevant experience; or an advanced degree and a minimum of 2 years of relevant experience.
Experience supporting quality engineering activities within a regulated manufacturing environment.
Experience analyzing technical or process data to drive investigations, root cause analysis, and corrective actions.
Experience creating, reviewing, or approving technical documentation supporting manufacturing or quality system activities.
Preferred Qualifications
Experience reviewing and approving engineering, validation, or quality documentation.
Experience with process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Experience developing, executing, and analyzing Test Method Validations.
Experience with risk management and validation documentation, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Master Validation Records.
Knowledge of statistical and quality engineering tools such as Design of Experiments (DOE), Statistical Process Control (SPC), capability studies, and hypothesis testing.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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 ex
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