Manufacturing Engineer
IPG Photonics Corporation - Marlborough, MA
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Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits. Job Summary We are looking for a hands-on Manufacturing Engineer to support the production of laser-based medical systems. This role sits right at the intersection of engineering, manufacturing, and quality - owning process robustness, documentation, and execution in a regulated medical device environment. If you like being on the floor, tightening processes, writing solid documentation, and supporting new products from early builds through production ramp - this is your lane. Key Responsibilities * Support day-to-day manufacturing of laser-based medical systems, including optical adapters and sub-assemblies * Develop, write, and maintain manufacturing work instructions, SOPs, and visual aids in compliance with FDA and ISO requirements * Author, execute, and support process validation activities including IQ / OQ / PQ * Partner closely with Quality to support deviations, NCMRs, CAPAs, and continuous improvement initiatives * Support New Product Introduction (NPI) activities, including: * Process development and transfer from R&D to Manufacturing * Pilot builds, design for manufacturability (DFM), and production ramp-up * Identify and implement process improvements to improve yield, cycle time, and product quality * Provide hands-on support to technicians during builds, troubleshooting, and training * Maintain accurate manufacturing documentation within PLM systems (Arena experience a plus) * Bachelor's degree in Manufacturing, Mechanical, Biomedical, or related Engineering discipline * Minimum 3 years of experience in a medical device manufacturing environment * Strong working knowledge of: * FDA QSR / ISO 13485 environments * Process documentation and controlled manufacturing records * IQ / OQ / PQ validation methodologies * Experience supporting production of electro-mechanical, optical, or laser-based systems * Comfortable working on the manufacturing floor and collaborating cross-functionally Preferred / Nice-to-Have * Experience with Arena PLM software * Prior experience supporting optical assemblies or laser-based products * Experience supporting manufacturing scale-up and process transfer What Success Looks Like in This Role * Clear, robust, and compliant work instructions that technicians actually use * Smooth execution of validations with minimal rework * Strong partnership with Quality and Operations * Faster, cleaner NPI transitions into production * Fewer surprises on the production floor
Created: 2026-04-02