Senior Manufacturing Process Engineer, Medical Devices

Abbott; United States; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Free HIP PPO medical coverage

Excellent retirement plan with high-em

Tuition reimbursement

Freedom 2 Save student debt program

Education benefits (FreeU)

Job summary

Abbott Vascular in Houston, TX seeks a Specialist in Manufacturing Process Development. This role designs and develops processes for life sciences products, coordinating with pilot-plant and production teams to ensure scalable, compliant operations.

You will lead qualification activities (IQ/OQ/PQ) and develop validation studies to ensure robust performance, regulatory alignment, and efficient production. Strong communication and engineering expertise are essential.

Qualifications

• Bachelor's Degree in Engineering/Technical discipline (Mechanical, Chemical, Electrical or Physics preferred).
• Minimum 5 years of relevant experience.
• Master's Degree would be ideal.
• Solid knowledge of general Engineering principles.
• Strong knowledge of design controls and regulations for medical device development (ISO13485, FDA).

Responsibilities

• Design and develop manufacturing processes for life sciences products.
• Lead equipment and manufacturing process qualification activities (IQ/OQ/PQ).
• Develop, execute, and maintain process validation documentation (PFMEA, DOE, TMV).
• Drive Lean Six Sigma and continuous improvement initiatives with data-driven problem solving.
• Collaborate with Quality, Regulatory Affairs, R&D, Manufacturing Operations, and Supply Chain.

Skills

Mechanical engineering

Chemical engineering

Communications skills

Lean Six Sigma

Statistical analysis

Education

Bachelor's degree

Master's degree

Tools

Lean Six Sigma

DOE

Job description

Abbott Vascular in Houston, TX seeks a Specialist in Manufacturing Process Development. This role designs and develops processes for life sciences products, coordinating with pilot-plant and production teams to ensure scalable, compliant operations.

You will lead qualification activities (IQ/OQ/PQ) and develop validation studies to ensure robust performance, regulatory alignment, and efficient production. Strong communication and engineering expertise are essential.