1 day ago Be among the first 25 applicantsDirect message the job poster from HERO RecruitmentSenior Recruitment Consultant at HERO Recruitment Ltd. Connect@hero.ieSenior Process Engineer - Medical DevicesWe’re looking for an experienced Senior Process Engineer to join our team, driving process development and optimization for medical devices. In this role, you'll enhance manufacturing processes, ensure compliance with industry standards, and lead process improvements across the team.Key Responsibilities:Standardize and optimize process development methodologies.Lead the scale-up of processes from pilot to full-scale production.Develop, validate, and document manufacturing processes.Ensure compliance with regulatory and quality standards (ISO 13485, FDA cGMP).Implement Lean, Six Sigma, and other methodologies for continuous improvement.Mentor junior engineers and technicians, fostering collaboration.Manage technical projects, timelines, and risk assessments.Required Qualifications:Bachelor’s degree in Engineering (Mechanical, Biomedical, or related field).6+ years of process development experience in the medical device industry.Hands-on experience with process validation (IQ, OQ, PQ) and SPC.Strong knowledge of medical device regulations and manufacturing technologies (injection moulding, automation, additive manufacturing).Experience leading cross-functional teams and managing projects.Preferred:Experience with DFM/DFA and cleanroom operations.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering, Manufacturing, and Product ManagementIndustriesMedical Equipment Manufacturing and Pharmaceutical Manufacturing
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