Sr. Quality Enginr

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.

A Day in the Life                                       

• Collaborating with cross-functional teams to develop comprehensive product risk management files, including the risk management plan, Hazard Analysis, 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.

Must Have

• 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 analyis, Post market surveillance, Design Controls for Medical Devices.
• Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
• Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
• Continuously monitor and stay updated with evolving safety regulations and guidelines to ensure PSUR compliance.
• Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR.
• 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.
• Deliver presentations to the QA organization on status and issues of assigned projects.
• Deliver trainings to departments outside of QA.
• Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.
• Hands-on experience on EU MDR.
• Previous experience working in a cross-functional team environment.
• Hands-on experience on Risk Management, Design Controls for Medical Devices.
• Participate when appropriate in audits.
• Familiar with ISO 13485, ISO 14971 and EU MDR and product specific industry standards.

• Experience in collaborating with regulatory affairs teams for submission of safety reports.

  
  

Minimum Qualification 

• B E or B.Tech in Mechanical/Biomedical Engineering
• Minimum 5-8 years of quality engineering experience or equivalence and overall 8-12 years of experience

Key Technical Competencies 

• 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. 

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.
 

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
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.

Learn more about our business, mission, and our commitment to diversity here