Senior Manufacturing Engineer

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

Senior Manufacturing Engineer - Medical Devices Process Validation | Design Transfer | Manufacturing Scale-Up

Ultimate Staffing is recruiting on behalf of a growing medical device manufacturer in Westminster, Colorado. This position will support manufacturing operations, process development, process validation, and design transfer activities for medical device products. The role works closely with Manufacturing, Quality, Technical Operations, and R&D teams to support new product introductions, continuous improvement initiatives, and manufacturing scale-up efforts.

Compensation & Benefits

• $115,000 - $125,000 base salary
• 10% annual bonus opportunity
• Equity grant
• Cell phone allowance
• Comprehensive benefits package

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.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• 10+ years of manufacturing or process engineering experience within a medical device environment.
• Experience working in FDA-regulated manufacturing environments.
• Proven experience leading process validations, including IQ/OQ/PQ.
• Experience developing, validating, troubleshooting, and improving manufacturing processes.
• Working knowledge of FDA Quality System Regulations and ISO 13485 requirements.
• Experience supporting production and resolving manufacturing process issues.
• Strong project management, communication, and cross-functional leadership skills.

Preferred Qualifications

• Experience with catheter-based, endovascular, or minimally invasive medical device products.
• Experience supporting design transfer and new product introduction (NPI) activities.
• Knowledge of DOE, SPC, MSA, and process capability studies.
• Experience with CAPA, PFMEA, risk management, and design controls.
• Cleanroom manufacturing experience.
• Lean Manufacturing and continuous improvement experience.

Location: Westminster, CO (Onsite)

Industry: Medical Device Manufacturing

Salary: $115,000 - $125,000 + 10% Bonus + Equity

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.