Reliability Eng II at Medtronic

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree and minimum of 2 years of relevant experience in Quality Engineering, Science OR master’s degree in engineering, Science, or technical discipline with a minimum of 0 years relevant experience
Experience in a highly regulated industry, preferably medical devices
Ability to work with cross functional groups to lead deliverables
Work with cross functional groups to investigate technical problems and apply critical thinking
Experience of working in complaint handling/post market quality team

Responsibilities

Owns and maintains periodic safety update reports (PSURs) by collaborating with Medical Safety, Regulatory and Clinical teams for all Aortic products
Supports Clinical Evaluation Updates for all Aortic products
Supports changes to released products in the field by being the quality reviewer on change orders
Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D, supplier quality, Manufacturing on a weekly basis to understand product complaints and assess field trends
Works closely with the customer quality experience management team, Returned Goods Investigation team and Manufacturing to understand product complaints received, update product codes and assist in investigations
Improve existing post market processes and systems to improve team performance and productivity
Assists in root cause investigations for CAPAs and NCMRs related to product performance, health risk assessments, product holds, product testing and risk file updates as needed for product failure trends seen in the field
Assists in conducting monthly trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required
Prepare appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team and customer quality experience management team
Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business
Supports internal and external audits

Skills

PSURs

Clinical Evaluation Updates

Change Orders

Root Cause Investigations

CAPAs

NCMRs

Complaint Trending

Risk Assessments

Regulatory Submissions

Post Market Surveillance

Quality Review

Field Actions

Product Investigations

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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