Senior Design Assurance Engineer - 12 month FTC at Medtronic

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Mechatronics, Science) with a minimum 4 years relevant experience
Dynamic team player working effectively and proactively on cross-functional teams
Ability to initiate and lead change, collaborate and create alignment, drive accountability, think critically and make sound decisions
Good communicator and fluent in English, both in writing and speaking
Experience in some form of technical writing beneficial
A working knowledge of Regulatory Standards as applicable (e.g. ISO13485/14971, 21 CFR and Corporate Quality standards)
Some formal knowledge of Complaint trending or Post Market Surveillance would be considered beneficial

Responsibilities

Provide Design Assurance support to various OU Sustaining & product Surveillance initiatives
Drive Engagement & mindfulness initiatives ensuring the wellbeing of yourself and your colleagues
Contribute to establishing best practice in accordance with ISO13485/14971, 21 CFR and Corporate Quality standards and Regulatory requirements
Contribute to establishing strong working cross functional relationships across the organization and with partners within a complex technical environment
Engage with risk management teams consisting of matrixed resources by providing focused technical guidance
Represent the CRDN Post Market department in supporting internal and external audits (MDR/MDSAP/FDA etc)
Contribute to the continuous improvement strategies
Partner with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes, and departmental interfaces
Work within the organisation to build, motivate and lead high performance teams

Skills

ISO 13485

ISO 14971

21 CFR

Risk Management

Regulatory Compliance

Auditing

MDR

MDSAP

FDA

Design Assurance

Post Market Surveillance

Quality Standards

Cross-functional Collaboration

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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