Senior Quality Engineer

Senior Quality Engineer

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

As a Senior Quality Engineer you will be a key member of the Medtronic Quality Engineering team responsible for maintaining highest standards of product reliability and patient well-being through precise risk assessment and management.
• Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, PFMEA, Control plans/reports, Master validation plan/report, DFMEA, and risk management report, adhering to ISO 14971 standards.
• Serving as a mentor to junior engineers, providing guidance and support in quality engineering practices within the realm of medical devices.

Responsibilities may include the following and other duties may be assigned.

• Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
• Subject matter expert in risk management for designated medical device products or platforms.
• Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
• Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements.
• Delivering presentations on project status and issues to the QA organization and providing training to other departments on relevant procedures and policies.
• Participating in audits and demonstrating the ability to effectively contribute as a team player in various roles, including contributor, subject matter expert, leader, and facilitator.
• Provide Quality support to facilitate resolution of product complaints and/or safety issues.
• Previous experience working in a cross-functional team environment.
• Familiar with statistical software tools (Minitab).
• Develop templates and trainings based on the quality system regulations, applicable standards and guidance.
• Independently review all deliverables to ensure compliance with development process and the standard.
• Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
• Hands-on experience on complaints analysis, Post market surveillance, Design Controls for Medical Devices.

Required Knowledge and Experience:

• BE/BTech with 8 to 12 years of experience in Risk Management experience.
• Familiar with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
• Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
• Good verbal and written communication skills.
• Fair Knowledge in post market surveillance.
• Familiar with DMAIC or DMADV(DFSS) methodologies.
  .Nice to Haves
• ASQ CQE, CQA, CSQE and/or CRE certification.
• ISO 9001 Internal Auditor / Lead Auditor Certification.
• ISO 13485 Internal Auditor / Lead Auditor Certification.
• Lean Six Sigma Green Belt or Black Belt

 

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. 

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Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. 

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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.

 

 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

Experience Level

Senior Level