Senior Manufacturing Engineer

24 hours ago


Marlborough, United States The Judge Group Full time

The Judge Group is seeking a Senior Manufacturing Engineer for a full time opportunity in Marlborough, MA.*Must have prior experience working with COMPLEX SINGLE USE Medical Disposables*Ideally with a background in prior Urethra or Endoscopy type medical devicesMust have Medical Device experienceJob Title: Senior Manufacturing Engineer - Medical DeviceType: Full Time Direct HireLocation: Marlborough, MAPosition Overview:We are seeking a Manufacturing Process Engineer to oversee the manufacturing processes within a company operated under ISO 13485. This role involves setting up processes for complex medical instruments, from design input through verification, validation, and manufacturing transfer stages. The Engineer will ensure compliance with global regulatory requirements and optimize manufacturing costs.Key Responsibilities:Manage manufacturing processes within an ISO 13485-operated companySet up and maintain manufacturing processes for complex medical instruments through all development phasesAssist in developing product specifications for design for manufacturing and service in coordination with other departmentsCoordinate the technical transfer of products and instruments from development to manufacturing, including analysis of customer complaints and recommendationsOptimize manufacturing costs for medical devices and instrumentsEnsure products meet stringent global regulatory requirements (e.g., FDA regulations, ISO 13485, CE mark)Develop and maintain design history files, PFMEA, and other documentation to support regulatory approval and manufacturingQualifications:Education:Bachelor's degree in Electrical or Mechanical EngineeringStrong knowledge of US and global regulatory requirements for medical devicesSolid project management skillsExperience:10+ years of work experience in a fast-paced medical device manufacturing environment, including capital equipment and disposable instrumentsThorough approach to developing manufacturing processes for multi-functional medical instruments (mechanical, optical, electronic, fluid control components)Experience coordinating development and operations teams, managing multiple suppliers, and adhering to strict schedules and budget boundariesKnowledge of modern lean manufacturing practices and MRP/ERP systemsExperience in verification and validation of special manufacturing processes (e.g., laser welding, sterilization, packaging)Experience implementing full or semi-automated production processes



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