Senior Process Engineer – Medical Devices, Lean & GMP

CooperSurgical; Stafford (TX); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical is seeking a Senior Process Engineer in Stafford, Texas. The engineer will lead manufacturing process design and optimization for medical devices, ensuring compliance with regulatory standards. They will improve process efficiency and mentor junior staff. Candidates should have a strong engineering background and experience in a regulated environment.

Key responsibilities include implementing process validation, data-driven analysis, and collaboration with cross-functional teams. Excellent benefits including medical coverage, 401(k), and parental leave are offered.

Qualifications

• 7+ years of experience in process engineering within a regulated manufacturing environment.
• Strong understanding of FDA QSR, ISO 13485 and risk management principles.
• Proven experience with problem-solving methodologies.

Responsibilities

• Lead the design and implementation of manufacturing processes for medical devices.
• Identify opportunities to improve process capability and efficiency.
• Plan and execute process validation activities compliant with regulations.

Skills

Process validation (IQ/OQ/PQ)

Root cause analysis

Data-driven analysis

Education

Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Chemical)

Job description

CooperSurgical is seeking a Senior Process Engineer in Stafford, Texas. The engineer will lead manufacturing process design and optimization for medical devices, ensuring compliance with regulatory standards. They will improve process efficiency and mentor junior staff. Candidates should have a strong engineering background and experience in a regulated environment.

Key responsibilities include implementing process validation, data-driven analysis, and collaboration with cross-functional teams. Excellent benefits including medical coverage, 401(k), and parental leave are offered.