Senior Medical Device Process Engineer — Lean & Validation

Ingersoll-Rand plc; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Ingersoll Rand is seeking a senior process engineer to lead validation, optimization, and continuous improvement of medical device manufacturing processes in Salt Lake City, Utah.

The role requires 5+ years in medical device engineering, strong skills in DOE, SPC, IQ/OQ/PQ, and proficiency with Minitab and CAD tools. You will mentor technicians and collaborate with NPI teams to ensure cost, quality, and delivery targets.

Qualifications

• Bachelor of science in a related engineering field from a four-year college or university.
• 5+ years of engineering experience within a medical device or contract medical device manufacturing environment.
• Working knowledge of typical medical device manufacturing techniques (tipping, thermoplastic injection molding, and extrusion).
• Proficiency in Microsoft Word, Excel, PowerPoint, and Minitab.
• Proven experience leading IQ/OQ/PQ and working to ISO 13485 / FDA 21 CFR 820.
• Practical experience using DOE, SPC, and Gage R&R; familiarity with control plans and PFMEA.
• Must have advanced skills in Microsoft Word, Excel, PowerPoint, and Minitab (or other statistical analysis software). SOLIDWORKS or CAD modeling software is a plus.
• Analytical and problem‑solving skills; detail‑oriented and able to produce accurate, professional documentation.
• Motivated and creative; operates effectively under pressure in a fast‑paced team environment.
• Excellent interpersonal skills with the ability to communicate needs and demands effectively.
• Drives continuous improvement and waste elimination through lean principles.

Responsibilities

• Promote a safety first mentality for all production areas, equipment, processes, and procedures.
• Provide guidance and day‑to‑day direction to technicians and engineers on assigned activities and best practices.
• Utilize lean process technology and automation during manufacturing execution to continuously improve the manufacturing environments driving cost leadership, world‑class quality, and customer satisfaction.
• Collaborate with new product introduction teams to ensure seamless implementation of new process flows and assist with transfer activities.
• Complete projects, report status, and document lessons learned efficiently; utilize project management tools to establish timelines, action item lists, assignments, due dates, and milestones.
• Lead process validation activities, including IQ, OQ, and PQ for equipment, tooling, and processes.
• Develop/improve processes and sampling activities, as well as tooling and manufacturing concepts that meet customer expectations on cost, quality, and delivery.
• Lead process improvement and waste elimination efforts through the application of lean principles; actively participate in continuous improvement events.
• Conduct DOE studies, process characterization, and root‑cause analysis to establish and maintain robust process windows.
• May communicate with existing customers on changes to existing processes, conveying timelines, and managing validation activities related to the change.
• Apply statistical tools to establish/monitor capability and verify effectiveness of improvements.
• Lead investigations and drive NCR/MRB/CAPA actions to closure in partnership with Quality and Operations; execute approved changes via change control.
• Demonstrates all corporate values.

Skills

DOE

SPC

Gage R&R

Lean principles

Problem solving

Analytical skills

Communication skills

Minitab

Microsoft Word, Excel, PowerPoint

IQ/OQ/PQ leadership

Quality systems compliance (ISO 13485,

MAD/Manufacturing process validation

CAD modeling (SOLIDWORKS)

Education

Bachelor of science in a related engineering field

Tools

SOLIDWORKS CAD

Job description

Ingersoll Rand is seeking a senior process engineer to lead validation, optimization, and continuous improvement of medical device manufacturing processes in Salt Lake City, Utah.

The role requires 5+ years in medical device engineering, strong skills in DOE, SPC, IQ/OQ/PQ, and proficiency with Minitab and CAD tools. You will mentor technicians and collaborate with NPI teams to ensure cost, quality, and delivery targets.