Process Engineer — Diagnostics Scale-Up & QC (Longmont)

Yoh Idibu; Boulder (CO); On-site; USD 95,000 - 105,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Certification and training

Job summary

Yoh Life Sciences is hiring a Process Engineer in Longmont, CO for a leading diagnostic company. The role supports transfer and development of new products and processes, backing manufacturing while improving existing equipment, product quality, and yield.

Responsibilities include sustaining operations with root cause analysis, implementing equipment modifications, and documenting IQ/OQ/PQ compliant procedures.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Five to seven (5-7) years in R&D or production with process improvement experience.
• Experience in a regulated environment (FDA, ISO) preferred.
• Project management experience preferred.
• Experience in medical device field, especially invitro diagnostics, preferred.
• ISO, PMP, Lean, Six Sigma, cGMP certifications preferred.

Responsibilities

• Lead sustaining support to operations using continuous improvement principles and root cause analysis for corrective actions.
• Ensure on-time equipment milestone deliveries to enable company growth.
• Recommend and implement equipment/process modifications to improve production yields and efficiency.
• Develop high-level capital equipment integration protocols for manufacturing.
• Conduct DOE and SPC analyses to target causes of yield loss and quality improvements.
• Document work products to meet IQ/OQ/PQ requirements and ensure traceability.
• Collaborate with design staff to ensure compatibility of processes with equipment.

Skills

Root cause analysis

Continuous improvement

Problem solving

Communication skills

Data analysis

Education

Bachelor’s degree in engineering

Master’s degree preferred

Tools

DOE

SPC

GR&R

Cpk analysis

IQ/OQ/PQ

SolidWorks

Windows

MS Office

Job description

Yoh Life Sciences is hiring a Process Engineer in Longmont, CO for a leading diagnostic company. The role supports transfer and development of new products and processes, backing manufacturing while improving existing equipment, product quality, and yield.

Responsibilities include sustaining operations with root cause analysis, implementing equipment modifications, and documenting IQ/OQ/PQ compliant procedures.