Careers That Change Lives 

In Senior Released Product Quality Engineer role, you will have the opportunity to work with a group of exceptionally capable and diverse Design Quality Engineers. This team of engineers support sustaining (Released Engineering) R&D projects and broader Quality Engineering initiatives, but will extend support to the New Product Development team as needed.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. 

To learn more about Inclusion & Diversity at Medtronic Click Here

The Neuroscience Portfolio provides innovative, life changing restorative therapies and services to meet the needs of people worldwide who suffer from a wide range of chronic medical conditions. The Neurovascular businesses develop products and procedural solutions for surgical applications which include brain and stroke therapy solutions.

Location:Irvine, CA

A Day in the Life

The Senior Released Product Quality Engineer will be responsible for:

• Collaborates with R&D, Regulatory, Operations, and Process Engineering to ensure high reliability and safety for NV products, and compliance to NV’s Quality system procedures.
• Implements and validate methods and procedures for inspections and Validation testing.
• performs statistical analysis to support quality decisions.
• Support CAPA and NCR dispositions. Support Field Corrective Actions and product holds. Support Issue Investigations across Released Product Engineering. Support Remediation projects and Design and Process changes.
• Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings, and guide wires to ensure quality products.
• Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis with proficiency in Minitab.
• Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA).
• Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971 and Good Documentation Practices (GDP).
• Provide Process Verification & Validation for product quality, including development and execution of protocols Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and TMV (Test Method Validations)).
• Coordinate root cause analysis using various quality tools (5 Whys, 6M and Ishikawa (Fishbone) Diagram). Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary.
• Identify Critical to Quality (CTQ) product features and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing).
• Create, Maintain, and implement Risk Management processes across products and processes.

Must Have (Minimum Requirements)

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering, Quality, and/or experience in a regulated industry 
• OR Advanced Degree in Engineering, Science, or technical field with 2 year of work experience in Engineering, Quality, and/or experience in a regulated industry.
• Strong experience in Test Method development and Validation skills/experience

Nice to Have (Preferred Qualifications)

• Advance degree in Engineering or Material Science, Polymers, Chemistry.
• Experience with QAD & SAP enterprise resource planning systems.
• Six sigma certification / ASQ certifications.
• Prior experience in medical device design quality is highly preferred.
• Strong Technical experience (Polymers, Material Science, and strength of Materials).
• Working Knowledge of medical device regulatory laws and standards
• Experience with inspection plans and inspection tools/equipment qualification.
• Experience managing product nonconformance (disposition, rework, closure).

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.
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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).