Description

You will own manufacturing process development, qualification, and validation for new product commercialization and product changes in the healthcare industry.

This role is on-site.

Responsibilities

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

Required Skills

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

Key Skills

Education

Bachelor's or Master's degrees