Manufacturing Engineer Job at Energy Jobline ZR in Sanford

Job DescriptionJob DescriptionJoin 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 ).
• 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, , 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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