Senior Manufacturing Process Engineer - Medical Devices

1223 Cardiovascular Systems Inc; Houston (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage

retirement plan with employer contrib

Tuition reimbursement

Student debt program

Job summary

Abbott in Houston, TX is seeking a Manufacturing Process Development Specialist to design and develop manufacturing processes for life sciences products within FDA-regulated environments.

You will lead IQ/OQ/PQ protocols, develop PFMEA and DOE studies, and drive Lean Six Sigma to improve yield and reduce scrap. Collaboration with Quality, Regulatory Affairs, R&D, and Supply Chain is essential to ensure scalable, compliant manufacturing solutions.

Qualifications

• Bachelor's degree in Engineering/Technical discipline or equivalent
• Master's degree preferred
• Minimum 5 years relevant experience
• Strong knowledge of ISO13485 and FDA regulations
• Experience with design for manufacture of medical devices and low-cost high-volume electronics

Responsibilities

• Design and develop manufacturing processes for life sciences products.
• Lead IQ/OQ/PQ protocols for medical device manufacturing.
• Develop PFMEA, DOE, and Process Characterization studies for regulatory compliance.
• Drive Lean Six Sigma and continuous improvement initiatives to improve yield and reduce scrap.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, and Supply Chain to enable scalable manufacturing.

Skills

Engineering principles

Design controls

Regulatory knowledge (ISO/FDA)

Communication skills

Medical device processes

DOE and problem solving

Education

Bachelor's degree in Engineering/Technical

Master's degree

Job description

Abbott in Houston, TX is seeking a Manufacturing Process Development Specialist to design and develop manufacturing processes for life sciences products within FDA-regulated environments.

You will lead IQ/OQ/PQ protocols, develop PFMEA and DOE studies, and drive Lean Six Sigma to improve yield and reduce scrap. Collaboration with Quality, Regulatory Affairs, R&D, and Supply Chain is essential to ensure scalable, compliant manufacturing solutions.