Plastics Process Engineer
- $85,000 - $95,000
- Tampa, FL
Drive Process Excellence in Class I–III Medical Device Manufacturing
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
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
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
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.
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.