Description

You will support manufacturing process development and qualification for new product commercialization and product changes within the healthcare or pharmaceutical industry.

Responsibilities

• Develop design verification test plans, perform design entry/exit reviews, and execute tests per design input requirements.
• Draft verification test reports for implantable and non-implantable medical device standards and regulations.
• Execute Process Validation including IQ, OQ, and PQ protocols and reports for existing and new processes.
• Remediate Design History Files and optimize design/process requirements to ensure regulatory compliance.
• Evaluate environmental health and safety for tools and products.

Required Skills

• Experience as a Manufacturing Engineer, Chemical Engineer, Validation Engineer, or Industrial Engineer.
• Knowledge of Process Validation (IQ, OQ, and PQ) protocols and reports.
• Understanding of medical device standards and regulations for implantable and non-implantable devices.
• Experience with Design History File (DHF) remediation.
• Ability to work under supervision.
• Willingness to travel and/or relocate to unanticipated client sites throughout the USA.
• Master’s degree in Manufacturing Engineering, Chemical Engineering, Industrial Engineering, or a closely related field.

Key Skills

Education

Bachelor's or Master's degrees