Recruitment Consultant at Sterling Engineering Ltd - Ireland & Europe
Job Summary:
Our Client is seeking a detail-oriented and experienced Senior Manufacturing Engineer to lead and optimize manufacturing processes for their medical device products. This role is critical in ensuring efficient production, compliance with regulatory standards, and continuous improvement of operations. The ideal candidate will bring strong engineering expertise, leadership skills, and a passion for advancing medical technologies.
Key Responsibilities:
* Lead the development, validation, and scaling of manufacturing processes for medical devices.
* Collaborate with R&D, Quality, and Regulatory teams to transition products from design to production.
* Own process documentation including PFMEAs, control plans, SOPs, work instructions, and device master records (DMRs).
* Implement and optimize lean manufacturing and Six Sigma methodologies to improve efficiency, reduce waste, and ensure product quality.
* Troubleshoot complex production issues and lead root cause analysis and CAPA efforts.
* Evaluate, qualify, and validate manufacturing equipment, tooling, and fixtures.
* Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations and standards.
* Support cost-reduction initiatives through design-for-manufacturability (DFM) and process improvements.
* Lead and mentor junior engineers and technicians on best practices and technical problem-solving.
* Manage project timelines, budgets, and cross-functional communication.
Qualifications:
* Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related field (Master’s preferred).
* Minimum 5–7 years of experience in a manufacturing engineering role within the medical device industry.
* Hands-on experience with FDA-regulated and ISO 13485-certified environments.
* Proven track record of process validation (IQ/OQ/PQ), equipment qualification, and statistical process control.
* Strong knowledge of lean manufacturing, Six Sigma (Green/Black Belt certification is a plus).
* Proficiency in CAD (e.g., SolidWorks), ERP systems, and engineering documentation tools.
* Excellent problem-solving, communication, and project management skills.
For a confidential conversation about the role contact Niall at +353 86 1980270 or Nfinnerty@sterlingengineeringeu.com. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Medical Equipment Manufacturing
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