Manufacturing/Process Engineer – Medical Device & DOE

Job Description

We are seeking a strong Mechanical Engineer with hands-on experience in DOE and validation within a medical device environment. The role involves process development and characterization for processes including drug filling, packaging, and testing. The engineer will be responsible for validation protocol writing and execution, data collection and statistical analysis, report writing, cross-functional coordination for approvals, and creation of work instructions for processes.

Key Skills

• Strong Mechanical Engineering experience with hands-on expertise in Design of Experiments (DOE), process development, and process characterization.
• Medical device experience involving drug filling, packaging, and testing processes.
• Experience with IQ/OQ/PQ validation protocol writing and validation execution.
• Experience collecting process data and using statistical analysis for report writing.

Required Qualifications

• Strong Mechanical Engineering background with hands-on experience in DOE and validation.
• Medical device experience.
• Experience with process development and characterization using DOE.
• Experience writing IQ/OQ/PQ validation protocols and executing validation activities.

Additional Skills

• Ability to coordinate and work with other departments for required approvals.
• Experience creating work instructions for processes.