Senior Manufacturing Engineer - Medical Device

Senior Manufacturing Engineer - Medical Device at Cornerstone Management Solutions Senior Manufacturing Engineer - Medical Device at Cornerstone Management Solutions in Santa Ana, California Posted in about 1 hour ago.

Type:

full-time

Job Description:

Senior Manufacturing Engineer Industry:

Medical Device Components, Elastomer Molding, LSR, EPDM, Rubber Processing A growing medical device component manufacturer in Southern California is seeking a Senior Manufacturing Engineer with strong experience in LSR, EPDM, rubber molding, automation, process validation and regulated manufacturing environments . This is a hands on technical role for someone who can work closely with production, tooling, quality, regulatory, vendors and leadership to develop scalable manufacturing processes for precision molded elastomer components. Position Overview The Senior Manufacturing Engineer will lead process development, validation, troubleshooting, automation initiatives and continuous improvement efforts for rubber molded medical device components produced in cleanroom or controlled manufacturing environments. This person should be comfortable moving between the production floor, technical documentation, vendor coordination, quality systems and hands on problem solving. Key Responsibilities Lead development, optimization and validation of manufacturing processes for medical device components using LSR and EPDM materials. Drive automation projects that reduce manual labor, improve throughput and strengthen process consistency. This may include robotics, vision systems and automated assembly equipment. Partner with tooling and equipment vendors to design, source and qualify molds, fixtures and automation systems for elastomer processing. Support new product introduction by ensuring product designs are manufacturable, scalable and aligned with medical device standards and risk management expectations. Develop and execute process validation protocols including IQ, OQ and PQ with clear traceability and compliant documentation. Create and maintain process flows, PFMEA, control plans, validation reports and SOPs. Optimize LSR and EPDM molding processes including injection molding, compression molding, material handling, mixing, curing and post processing. Troubleshoot molding defects, contamination concerns, tooling wear and process variability in controlled production environments. Work closely with Quality and Regulatory teams on audits, CAPA, nonconformance resolution and change control. Specify and qualify molds, tooling and automated equipment compatible with cleanroom and medical grade production requirements. Implement in line inspection and validation technologies for critical to quality features. Support preventive and predictive maintenance strategies for manufacturing equipment. Train production operators and technicians on complex parts, assemblies and processes when needed. Required Qualifications Bachelor's degree in Engineering or at least 6 years of technical experience in a Rubber or Silicone injection molding environment. Hands on experience with liquid silicone rubber, EPDM and rubber molding processes. Process automation experience in a manufacturing environment. Direct experience with MRP systems. Preferred Qualifications CAD experience. Lean Six Sigma experience. Experience working with 3 axis robots. Bilingual English and Spanish skills. Ideal Background Medical device component manufacturing, elastomer molding, silicone molding or rubber molding experience. A process driven engineer who can move between the production floor, vendors, quality documentation and technical troubleshooting. Strong practical judgment around automation, validation, tooling and manufacturability. Comfortable working in a regulated manufacturing culture where documentation, consistency and execution matter. Keywords 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, Orange County Manufacturing,