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
#J-18808-Ljbffr