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• Prepare and compile product post market data and findings into comprehensive Periodic Safety Update Reports (PSURs) in compliance with regulatory requirements.• 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:
Collaborate with cross-functional teams to gather and analyze data related to the performance and safety of medical devices.
Drafting and authoring PSUR or CER documents.
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.
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.
Collaborates with engineering, regulatory affairs and manufacturing functions to ensure submission of safety reports.
Deliver presentations and trainings to the QA organization on status and issues of assigned projects.
Participate when appropriate in audits.
Required Knowledge and Experience:
B E or B. Tech in Mechanical/Biomedical Engineering
Minimum 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience.
Familiar with Literature review, PMCF,IMDRF coding, CAPA and NCMR.
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, Risk Management, Design Controls for Medical Devices.
Familiar with ISO 13485, ISO 14971,21 CFR part 820, 21 CFR part 11 and EU MDR and product specific industry standards.
Understanding of post-market surveillance processes and adverse event reporting.
Knowledge of risk management principles and hazard analysis in the context of medical devices.
Good verbal and written communication skills including plan / report development.
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.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
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.
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).About Medtronic
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
