Manufacturing EngineerOmega Medical Imaging LLC • Sanford, FL, US

Manufacturing Engineer

Omega Medical Imaging LLC • Sanford, FL, US

3 days ago

Job type

Full-time

Quick Apply

Job description

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. Powered by JazzHR

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Manufacturing Engineer • Sanford, FL, US

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