Injection Molding Engineer (LSM)

Job Description Job Description Senior Manufacturing Engineer Confidential medical device component manufacturer | Southern California Focus: LSR, EPDM, automation, cleanroom production, validation and scalable manufacturing The company is seeking a Senior Manufacturing Engineer with strong LSR, EPDM and rubber molding experience. This person will support process development, validation, troubleshooting, automation and continuous improvement for precision medical device components produced in cleanroom or controlled manufacturing environments. Key Responsibilities • Develop, optimize and validate LSR and EPDM molding processes. • Lead automation improvements involving robotics, vision systems and automated assembly. • Work with tooling and equipment vendors on molds, fixtures and automation systems. • Support NPI, manufacturability, process scale up and medical device documentation. • Develop and execute IQ, OQ and PQ validation protocols. • Maintain PFMEA, control plans, SOPs, validation reports and process documentation. • Troubleshoot molding defects, contamination issues, tooling wear and process variation. • Partner with Quality and Regulatory on audits, CAPA, nonconformance and change control. Required Qualifications • Bachelor’s degree in Engineering or at least 6 years of technical injection molding experience. • Hands on experience with LSR, EPDM or rubber molding processes. • Manufacturing automation experience. • MRP system experience. • Strong communication skills and ability to work in a team based manufacturing environment. Preferred Qualifications • CAD experience. • Lean Six Sigma experience. • Experience with 3 axis robots. • Bilingual English and Spanish skills. Ideal Background Medical device components, silicone molding, rubber molding, elastomer processing, cleanroom manufacturing, automation, validation and process troubleshooting. Keyword Search Terms Senior Manufacturing Engineer, Manufacturing Engineer, Medical Device Manufacturing, Medical Device Components, Liquid Silicone Rubber, LSR, LIM, Liquid Injection Molding, EPDM, Rubber Molding, Elastomer Processing, Injection Molding, Compression Molding, Cleanroom Manufacturing, ISO 13485, FDA, IQ, OQ, PQ, Process Validation, NPI, New Product Introduction, PFMEA, Control Plans, SOPs, CAPA, Nonconformance, Change Control, Automation, Process Automation, Robotics, 3 Axis Robots, Vision Systems, Automated Assembly, In Line Inspection, Mold Design, Tooling, Fixtures, Vendor Management, CTQ, Critical To Quality, Biocompatibility, Material Handling, Mixing, Curing, Post Processing, Molding Defects, Contamination Control, Process Optimization, Continuous Improvement, Lean Six Sigma, MRP, CAD, Medical Elastomers, Silicone Molding, Rubber Components, Seals, Gaskets, Regulated Manufacturing, Southern California, San Clemente, Orange County Manufacturing, Bilingual English Spanish Company Description Medical device components, precision elastomers and engineered rubber components Focus: LSR, EPDM, automation, cleanroom production, validation and scalable manufacturing Company Description Medical device components, precision elastomers and engineered rubber components\nFocus: LSR, EPDM, automation, cleanroom production, validation and scalable manufacturing