Senior Manufacturing Process Engineer - Medical Devices

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Abbott in Houston, TX seeks a Specialist professional in Manufacturing Process Development to design and develop manufacturing processes for life sciences products, transferring technology from research to production.

You will lead IQ, OQ, PQ protocols, develop validation studies (PFMEA, DOE, TMV), drive Lean Six Sigma improvements, and partner with Quality, Regulatory, R&D, Manufacturing Operations, and Supply Chain to enable scalable, compliant operations in FDA-regulated environments.

Qualifications

• Engineering/Technical discipline in mechanical, chemical, electrical or physics.
• Bachelor's degree and, ideally, a Master's degree.
• Minimum 5 years of relevant experience.
• Strong knowledge of design controls and regulations (ISO13485, FDA).

Responsibilities

• Design and develop manufacturing processes for life science products.
• Lead IQ/OQ/PQ protocols in medical device manufacturing.
• Develop validation docs: PFMEA, DOE, TMV for regulatory compliance.
• Drive Lean Six Sigma and continuous improvement initiatives.
• Collaborate with Quality, Regulatory, R&D, Manufacturing Operations, and Supply Chain.

Skills

Mechanical Engineering

Chemical Engineering

Written and Verbal Communication

Education

Bachelor's Degree (± 16 years)

Master's Degree (± 18 years) Ideal

Job description

Abbott in Houston, TX seeks a Specialist professional in Manufacturing Process Development to design and develop manufacturing processes for life sciences products, transferring technology from research to production.

You will lead IQ, OQ, PQ protocols, develop validation studies (PFMEA, DOE, TMV), drive Lean Six Sigma improvements, and partner with Quality, Regulatory, R&D, Manufacturing Operations, and Supply Chain to enable scalable, compliant operations in FDA-regulated environments.