Manufacturing Engineer
Manufacturing Engineer – Medical Device Product Launch (Eyelid Surgery Device) Location: Los Angeles, CA area and remote work Employment Type: Full-Time Department: Operations / Manufacturing Engineering About Us We are an innovative medical device company focused on advancing surgical outcomes through precision-engineered solutions. Our newest product—a specialized plastic device designed for eyelid surgery—is set to launch in three months. To support this exciting milestone, we are seeking an experienced Manufacturing Engineer to join our growing team and lead production readiness activities from pilot to scale-up. Key Responsibilities Develop and implement manufacturing processes for the company’s new eyelid surgery device, ensuring compliance with FDA, ISO 13485, and GMP requirements. Collaborate with R\&D, Quality, and Supply Chain teams to transition the product from design to full-scale production. Design and optimize assembly fixtures, tooling, and equipment to ensure high-quality, efficient production. Author and maintain manufacturing documentation, including work instructions, process validations, and risk assessments. Identify and resolve production issues, optimizing for cost, quality, and yield. Support supplier qualifications and oversee incoming inspection standards for plastic molded components. Lead process validation (IQ/OQ/PQ) and continuous improvement initiatives. Qualifications Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering (Master’s preferred). 3–7 years of experience in medical device manufacturing, particularly with plastics or small assemblies. Strong understanding of design for manufacturability (DFM) and design transfer processes. Hands-on experience with injection molding, assembly automation, and process validation. Working knowledge of FDA QSR, ISO 13485, and GMP standards. Proficiency with CAD tools (SolidWorks preferred) and statistical analysis software (Minitab or equivalent). Excellent communication, project management, and problem-solving skills. Why Join Us Be part of a mission-driven team improving surgical precision and patient outcomes. Opportunity to shape the production launch of a new Class I/II medical device. Collaborative culture that values innovation, quality, and scientific excellence. Salary Range: $96,000 – 120,000/year To Apply: Please send your resume and a brief cover letter outlining your relevant experience to Rpiepenbrock@osheru.com. Pay: $96,000.00 - $120,000.00 per year Benefits: 401(k) Dental insurance Health insurance Paid time off Work Location: Remote