Senior Research & Development Engineer I Sustaining & Lifecycle

Overview

Senior Research & Development Engineer I Sustaining & Lifecycle – Galway, Ireland.

Role located in Ballybrit, Galway.

Reports to : R&D Project Manager.

Job Description

Senior R&D Engineer I supports managing and delivering R&D activities associated with the lifecycle management of the portfolio of products for treatment of acute ischemic stroke with significant technical challenges.

Responsibilities include lifecycle management activities such as material changes, process improvements, regulatory submissions, shelf-life studies, responding to sales & marketing requests, and investigations of returned products.

Responsibilities

Acquire in-depth knowledge of current products from a technical perspective (design, materials, performance, manufacturing process).

Lead product / process optimization projects in liaison with Supply Chain and Quality.

Support second supplier and / or technical transfer projects.

Manage sub-parts of projects as part of a larger team; provide direction and mentorship to less experienced engineers or technicians.

Support regulatory submissions and lead Design Verification / Validation studies as required by regional authorities.

Lead product shelf-life studies through Design Verification testing.

Investigate product complaints and analyze returned devices.

Support CAPA and Non-Conformance processes; evaluate and scope process / material / vendor changes.

Support labeling changes and implementation; assist Sales and Marketing with product characterization, competitive testing, and field training.

Develop and deliver project plans aligned to performance, time, and cost targets; liaise with external resources and suppliers to achieve goals.

Identify and manage key risks throughout the product lifecycle; write procedures, protocols, specifications, and reports.

Evaluate physician / user techniques and develop product training materials; support developing marketing materials (presentations / videos / demos).

Other duties as assigned or required.

Qualifications

Minimum 4 years' experience in all stages of medical device design and development (including design with SolidWorks, prototyping, and testing).

Specific experience with Medical Devices, cardiovascular or neurovascular implants / instruments including catheters, stents, delivery systems.

Strong design and technical ability based on fundamental engineering principles.

Data review and statistical methods skills (Minitab).

Excellent writing, presentation, and verbal communication skills; ability to work independently and as a team.

Results- and deadline-driven with the ability to handle multiple tasks in a fast-paced environment.

Strong interpersonal skills and a proactive, self-starting attitude.

Location & Travel

Onsite role based in Galway, Ireland with flexible work arrangements per management and J&J Flexible Work policy.

Travel may be required up to 20%.

What Awaits You

Opportunity to work with a ground-breaking biomedical leader.

Global market leader, dynamic environment, challenging projects, and opportunities for personal and professional development.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Hospitals and Health Care

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