Senior Medical Device Manufacturing Engineer – Process Validation

Ultimate Staffing; Westminster (CO); On-site; USD 115,000 - 125,000; Full time

Benefits offered by this job

Equity grant

Cell phone allowance

Comprehensive benefits package

10% annual bonus

Job summary

Ultimate Staffing is recruiting on behalf of a growing medical device manufacturer in Westminster, Colorado. The Senior Manufacturing Engineer will support manufacturing operations, process development, validation, design transfer, and scale-up activities for medical device products.

The role collaborates with Manufacturing, Quality, Technical Operations, and R&D to enable new product introductions and continuous improvement, with focus on IQ/OQ/PQ validation and robust documentation.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering or a related technical discipline.

Responsibilities

• Lead the development, validation, and continuous improvement of manufacturing processes and technologies.
• Support new product introductions, design transfers, and manufacturing scale-up initiatives.
• Author and execute IQ/OQ/PQ protocols and validation reports.
• Develop and maintain manufacturing documentation including SOPs, work instructions, engineering change orders, and validation records.
• Apply statistical methods including DOE, SPC, MSA/Gage R&R, and process capability analysis to improve process performance.
• Troubleshoot manufacturing issues and identify root causes to improve quality, yield, and efficiency.
• Drive cost reduction, scrap reduction, and continuous improvement initiatives.
• Lead and support PFMEA, CAPA, and risk management activities.
• Collaborate with Quality, Manufacturing, Operations, and R&D teams throughout the product lifecycle.
• Evaluate, qualify, and implement manufacturing equipment, tooling, fixtures, and production systems.
• Monitor manufacturing metrics and implement corrective actions as needed.
• Support cleanroom manufacturing activities and validations.
• Provide technical guidance and mentorship to production personnel and junior engineering staff.

Skills

Process validation

IQ/OQ/PQ

FDA regulations

DOE

SPC

MSA/Gage R&R

CAPA

PFMEA

Lean manufacturing

Cross-functional leadership

Education

Bachelor's degree in Mechanical Engineering; Biomedical Engineering; Manufacturing Engineering

Job description

Ultimate Staffing is recruiting on behalf of a growing medical device manufacturer in Westminster, Colorado. The Senior Manufacturing Engineer will support manufacturing operations, process development, validation, design transfer, and scale-up activities for medical device products.

The role collaborates with Manufacturing, Quality, Technical Operations, and R&D to enable new product introductions and continuous improvement, with focus on IQ/OQ/PQ validation and robust documentation.