MDR Vigilance Specialist I

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.

Write Investigation Summaries based on technical product analysis information provided by the plant.

A Good knowledge in Electrical and Electronics Domains: A good understanding of electrical and electronic systems, particularly as they relate to complex medical devices like ventilators.

Knowledge of Biomedical Equipment: Familiarity with the functionality, design, and clinical application

of biomedical devices, including troubleshooting and root cause analysis.

Technical Know-How on Operational Aspects(Good to have, not a must): Hands-on experience or a strong theoretical understanding of the operational mechanics of ventilators, including software-driven systems, sensors, and pneumatic components.

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

• Evaluates incoming complaint information and maintains the record in the electronic database.
• Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.
• Determines Reportability of complaints to Government Agencies.
• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
• Writes investigation summaries based on technical product analysis information provided;
• Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
• Liaison with groups who perform additional investigation and who prepare written record of investigation.
• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
• Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.
• Reviews and interprets risk management documentation as it applies to the complaint event.
• Interacts with multiple departments within Medtronic - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.
• Interacts with groups external to Medtronic - MITG, such as customers, vendors, health care professional

Required knowledge and experience:

• Bachelor degree; Engineering or Science degrees preferred (e.g.EE, ME, Biomedical Engineering)
• 1 to 3 years quality assurance or regulatory experience in medical or pharmaceutical industry.
• Computer literate with skills in Word, Excel, Access, PowerPoint and database trending analysis
• Strong typing skills and ability to write business documents with minimal supervision.
• Strong verbal and written communication skills and ability to work in a team oriented environment
• Ability to multitask.
• Ability to understand the functionality / intended use of complex medical devices.
• Minimum travel may be required.

Nice to Haves
- Knowledge of medical devices, their development and quality control.
- Knowledge of FDA, MEDDEV, Canadian Regulations.
- Technical Writing experience.
- A Good knowledge in Electrical and Electronics Domains: A good understanding of electrical and electronic systems, particularly as they relate to complex medical devices like ventilators.

Knowledge of Biomedical Equipment: Familiarity with the functionality, design, and clinical application

of biomedical devices, including troubleshooting and root cause analysis.

Technical Know-How on Operational Aspects(Good to have, not a must): Hands-on experience or a strong theoretical understanding of the operational mechanics of ventilators, including software-driven systems, sensors, and pneumatic components.

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.

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

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.