Senior Medical Device Manufacturing Engineer - Scale-Up

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

Benefits offered by this job

10% annual bonus

Equity grant

Cell phone allowance

Comprehensive benefits package

Job summary

Ultimate Staffing is recruiting for a Senior Manufacturing Engineer in Westminster, CO, to support medical device manufacturing operations, process development, validation, and design transfer. You will collaborate with Quality, R&D, and Operations to drive new product introductions and continuous improvement across the product lifecycle.

The role requires 10+ years in medical device manufacturing, FDA-regulated experience, and expertise in IQ/OQ/PQ.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• 10+ years of manufacturing or process engineering experience in a medical device environment.
• Experience in FDA-regulated manufacturing environments.
• Proven experience leading process validations (IQ/OQ/PQ).
• Experience developing, validating, and improving manufacturing processes.

Responsibilities

• Lead development, validation, and continuous improvement of manufacturing processes and technologies.
• Support new product introductions, design transfers, and scale-up initiatives.
• Author and execute IQ/OQ/PQ protocols and validation reports.
• Develop and maintain manufacturing documentation (SOPs, work instructions, ECNs, validation records).
• Apply DOE, SPC, MSA/Gage R&R, and process capability analysis to improve performance.
• Troubleshoot issues, identify root causes, and improve quality, yield, and efficiency.
• Drive cost, scrap reduction, and continuous improvement initiatives.
• Lead PFMEA, CAPA, and risk management activities.
• Collaborate with Quality, Manufacturing, Operations, and R&D across product lifecycles.
• Evaluate, qualify, and implement equipment, tooling, fixtures, and production systems.
• Monitor metrics and implement corrective actions; support cleanroom manufacturing.

Skills

Project management

Communication

Cross-functional leadership

Education

Bachelor's degree in Mechanical/ Biomedical/ Manufacturing Eng.

Job description

Ultimate Staffing is recruiting for a Senior Manufacturing Engineer in Westminster, CO, to support medical device manufacturing operations, process development, validation, and design transfer. You will collaborate with Quality, R&D, and Operations to drive new product introductions and continuous improvement across the product lifecycle.

The role requires 10+ years in medical device manufacturing, FDA-regulated experience, and expertise in IQ/OQ/PQ.