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Manufacturing Engineer II / III Polymeric Heart Valves
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Foldax Inc.
Salt Lake City, UT (In Person)
$115,000 Salary, Full-Time
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Job Description
Manufacturing Engineer
II / III
- Polymeric Heart Valves Foldax Inc. Salt Lake City, UT Job Details Full-time $90,000 - $140,000 a year 1 hour ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Mechanical blueprint interpretation 3D modeling software 5S GD&T Bachelor's degree in engineering Electrical systems Organizational skills SolidWorks Robotics Mechanical knowledge Cross-functional communication Time management Full Job Description Manufacturing EngineerII / III
-Polymeric Heart Valves Location:
Salt Lake City, UT Employment Type:
Full-Time Pay:
$90,000.00 - $140,000.00 per year Position Overview The Manufacturing Engineer II/III plays a critical role in owning, sustaining, and improving manufacturing processes for next-generation polymeric heart valves. This position provides advanced technical leadership on the production floor and serves as a key liaison between Manufacturing, R D, Quality, and Process Engineering. At the senior level, this role is expected to independently drive process development, lead cross-functional projects, and champion continuous improvement initiatives in a highly regulated, fast-paced environment. Key Responsibilities- Process Ownership & Support Lead day-to-day technical support for manufacturing operations, ensuring process stability, repeatability, and product quality. Serve as the primary engineering owner for one or more manufacturing processes (e.g., polymer preparation, molding, assembly, or test).
- Process Development & Optimization Design, develop, and optimize manufacturing processes to improve yield, efficiency, and scalability. Analyze process capability, identify sources of variability, and implement robust solutions.
- Cross-Functional Collaboration Partner with R D to transition new products and processes into manufacturing (NPI).
GMP, ISO
13485, and FDA requirements.- Documentation & Validation Author and maintain manufacturing work instructions, test methods, and equipment specifications. Lead and execute process validations (IQ/OQ/PQ) and support design transfer activities.
- Testing & Data Analysis Plan and conduct testing of raw materials, in-process components, and finished devices. Perform statistical analysis to support process improvements and risk mitigation.
- Continuous Improvement Lead or participate in Lean/Kaizen initiatives, applying tools such as root cause analysis (RCA), 5 Whys, DOE, SPC, and value stream mapping. Drive efforts to reduce waste, improve throughput, and enhance product quality.
- Equipment & Tooling Specify, qualify, and support manufacturing equipment and tooling. Troubleshoot complex equipment and process issues with a structured, data-driven approach. Qualifications