Drive Process Excellence in Class I–III Medical Device Manufacturing This Jobot Job is hosted by: Ryan Weingardt Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $85,000 - $95,000 per year A bit about us: We are a Florida-based injection molder specializing in high-precision, low-to-mid volume production for the medical device and life sciences industries. With ISO Class 7 and 8 cleanroom capabilities and a track record of producing Class I, II, and III devices, we pride ourselves on delivering turnkey, compliant, and quality-driven solutions for global OEMs. Why join us? ISO 13485-certified and FDA-registered facility Hands-on, fast-paced medical molding environment with strong engineering culture Emphasis on continuous improvement, validation rigor, and patient safety Small enough to be agile, big enough to invest in top-tier talent and technology Job Details Seeking an experienced Process Engineer to support and optimize injection molding operations for complex medical device components. You’ll collaborate closely with cross-functional teams in Validation, Tooling, R&D, and Quality to launch new products and maintain robust manufacturing processes under ISO 13485 compliance. Core Responsibilities: Develop, validate, and optimize molding processes for Class I, II, and III medical devices Lead IQ/OQ/PQ protocols, Gage R&R, and DOE studies in alignment with FDA and ISO 13485 standards Utilize RJG methodology and scientific molding techniques to troubleshoot and sustain high-quality output Interface with R&D and Project Engineering on new product introductions (NPI) and tooling changes Generate and maintain technical documentation: PFMEA, Control Plans, Process Sheets, and Master Validation Plans Work hands-on with mold setup, parameter development, and process characterization Ideal Experience: 8+ years in a regulated medical device manufacturing environment Expertise in injection molding, laser welding, laser marking, and electromechanical assembly SolidWorks proficiency for fixture design and packaging development RJG training and scientific molding expertise Experience with validation strategy (ISO 13485, FDA 21 CFR Part 820) Demonstrated success in process development, troubleshooting, and technical leadership Interested in hearing more? Easy Apply now by clicking the "Apply" button. Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
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