Process Development Engineer

Job Description: We are seeking a Process Development Contractor with 1–3 years of experience in the medical device industry to support process development, equipment implementation, validation, and continuous improvement activities. The ideal candidate will be responsible for developing and executing process validations, analyzing equipment suitability, conducting design of experiments, and evaluating testing data to improve product quality and manufacturing efficiency. This role also involves preparing technical documentation, supporting process and tooling development, collaborating with cross-functional teams, and ensuring safe, efficient, and compliant manufacturing processes.

Process Development and Process Validation Test Method Validation (TMV) and Inspection Method Validation (IMV) Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Product Performance Qualification (PPQ) Design of Experiments (DOE) and Data Analysis Equipment Specification, Acquisition, and Implementation Manufacturing Process Improvement Validation Protocols and Risk Assessments Standard Operating Procedures (SOPs) and Technical Documentation Tooling Development and Equipment Suitability Assessment Required Qualifications1–3 years of relevant professional experience. Experience in the medical device industry. Bachelor's degree preferred. Understanding of engineering principles, theories, concepts, practices, and techniques. Ability to analyze problems and develop solutions using fundamental engineering principles. Experience authoring and executing process validations.