Overview
STEM Recruitment Partners is working with a medical device company based in West Dublin that is seeking an experienced Senior Process Engineer to support manufacturing in the design, development, and implementation of advanced and high-volume manufacturing processes for medical devices.
This role will play a key part in supporting new product introductions, managing CMOs, and providing expertise related to process development and automation design for their single-use medical device.
Contract and Compensation
12-month contract
Up to €75-85/hour DOE
3 days onsite per week with travel up to 20%
Key Responsibilities
* Design and optimize robust manufacturing processes to ensure high yield and consistent product quality.
* Lead process development from concept through to full-scale production on the manufacturing floor.
* Support a large tech transfer project with an external plastics supplier in the US.
* Collaborate with R&D teams to transition new devices from development through validation into production.
* Manage external vendors for the design, build, and integration of new manufacturing equipment.
* Prepare and maintain process documentation, author and execute validation protocols (IQ/OQ/PQ).
* Drive continuous improvement initiatives for efficiency, automation, and product quality.
* Oversee commissioning, scaling, and validation of new technologies (focus on microcatheter production).
* Partner with EHS to conduct risk assessments for new equipment, materials, or processes.
* Act as a subject matter expert in specific manufacturing technologies and mentor colleagues.
Qualifications
* Bachelor's degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related).
* Minimum 10 years' experience in the medical device manufacturing industry, especially medical device process development and automation.
* Solid knowledge of medical device regulations (FDA 21 CFR Parts 801 & 820, design controls, ISO13485). Proven success in developing 510K/PMA regulated products.
* Excellent analytical, problem-solving, and project management skills.
* Strong communication and interpersonal skills; ability to influence, collaborate, and deliver cross-functionally.
* Proficiency in MS Office and project management tools.
Seniorities and Employment
* Seniority level: Mid-Senior level
* Employment type: Contract
* Job function: Project Management, Engineering, and Manufacturing
* Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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