Join Omega Medical Imaging – Innovators in Interventional Imaging
Location: Sanford, FL
Position: Manufacturing Engineer (Process & NPI) – Class II X-Ray Systems
Employment Type: Full-Time | On-site, Monday-Friday, 8:00 am – 5:00 pm
Experience Level: [Mid]
About Omega Medical Imaging
Omega is a U.S.-based manufacturer of the world’s only AI-powered Region of Interest (ROI) X-ray system for interventional imaging (fluoro & cine). Our technology is not just innovative, it’s transformative, delivering up to 84% additional radiation reduction for patients and everyone in the procedure room, as proven by peer-reviewed studies.
We proudly design, manufacture, and support our solutions in-house, fostering a collaborative, mission-driven culture where every team member plays a role in helping us shape the future of medical imaging.
We believe ROI-based radiation reduction should become the standard of care. We’re not just designing and selling solutions —we’re starting a movement.
About the Role:
We build high-mix/low-volume interventional X-ray systems that combine precision mechatronics, metal fabrication, complex cabling, coatings, and embedded/software loading. We are hiring 2 experienced, entrepreneurial Manufacturing Engineers to be the hands-on bridge between Product Engineering and the factory – owning stable, compliant, and scalable production. Each person will lead one focus, but collaborate daily:
- Process & Production Systems: own routings, toolings/fixtures, line setup, and continuous improvement
- NPI & Design Transfer: own transfer from design outputs to production specifications, pilot builds, and validation
Key Responsibilities
- Translate design outputs into clear, visual, bilingual (EN/ES) work instructions, checklists, and travelers that meet 21 CFR 820 / QMSR and ISO 13485.
- Drive DFM/DFA and manufacturability feedback in design reviews; run PFMEAs and risk mitigations that reduce defects and touch‑time
- Build and optimize routings, BOM structures, and master data in our MRP/ERP; create kits, work centers, and capacity/load rules that fit high‑mix/low‑volume flow.
- Lead line setup for mechanical, electrical, and motion assemblies; specify fixtures, torque tools, ESD/grounding, test stations, and poka‑yoke
- Plan and execute validations (IQ/OQ/PQ) and process characterizations; establish critical process parameters and release criteria
- Troubleshoot builds in real time with technicians; drive RCCA/CAPA and support SCARs when supplier issues arise
- Own ECOs and document control in partnership with Quality; keep DHF/DMR/Device Master Records and travelers in sync
- Reduce NCMRs and rework through standard work, takt‑aligned layouts, 5S/visual management, and lean experiments
- Coordinate incoming inspection criteria and gauge selection; implement acceptance sampling and first‑article requirements
- Support pilot builds, FAIs, and readiness reviews for each transfer; define exit criteria and ramp plans to steady state
- Champion safety and EHS practices across paint/coatings, metal shop, cable assembly, and system integration areas
- Communicate across a multi‑lingual floor, coach technicians and peers with high EQ and respect
Qualifications & Skills
- Bachelor’s in mechanical/manufacturing/industrial/electrical engineering or equivalent practical experience
- 4–10 years hands‑on manufacturing engineering in regulated electromechanical products (medical device preferred)
- Proficiency with MRP/ERP (e.g., routings, BOMs, ECOs, work centers, capacity planning)
- Strong CAD literacy for reading models/drawings; comfortable creating simple fixtures and markups
- Demonstrated skill writing crisp, visual work instructions and checklists; bilingual English/Spanish a plus
- Working knowledge of FDA QSR / QMSR and ISO 13485; experience with IQ/OQ/PQ and CAPA
- Practical lean toolkit (standard work, takt/flow in HMLV, 5S, SMED, mistake‑proofing, value stream mapping)
- Excellent troubleshooting and collaboration skills; calm under pressure, high emotional intelligence
- Bonus: cable/harness build/test, coatings/paint processes, motion control/servo tuning, PLC or embedded load & test
- Ability to lift to 35 lbs
Why Join Omega?
- Be part of a pioneering team pushing the boundaries of AI medical imaging
- Thrive in a fast-paced, demanding, entrepreneurial environment with the opportunity to have an impact
- Enjoy a workplace rooted in accountability, collaboration, integrity, and excellence
What We Offer
- Competitive base salary
- PTO and paid holidays
- 401(k) with Safe Harbor company match
- Tuition reimbursement
- Medical, dental, vision, disability, and life insurance
- Health Savings Account (HSA) with employer match
Ready to Make a Difference?
Apply today and help us transform the future of medical imaging.
Omega Medical Imaging, LLC is an Equal Opportunity Employer (EOE) and Drug-Free Workplace (DFW).
Must be legally authorized to work in the U.S., sponsorship not available.
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