Manufacturing Engineer

We're looking for a Manufacturing Engineer with expertise in the medical device industry on an hourly rate contracting basis. In this role, you'll be a key player in ensuring our manufacturing processes are robust, compliant, and efficient.

Responsibilities:

• Develop and approve validation protocols (IQ, OQ, PQ) and process characterization reports.
• Write, review, and approve Repeat Action Assessments (RAA) and Acceptance Equipment Lists (AELs).
• Update, review, and approve manufacturing instructions (SGOIs) and Manufacturing Execution System (MES) documents.
• Serve as the primary owner for DMR remediation NC/CAPAs as needed.
• Contribute to the completion of all DMR remediation activities, ensuring they are completed within required timelines.

What We're Looking For:

• A minimum of 2+ years of experience in a manufacturing, quality, or new product introduction (NPI) role within the medical device sector.
• Familiarity with medical device manufacturing documentation, including Standard Operating Procedures (SOPs), change control, and process risk assessments (PFMEA).
• Strong understanding of validation documentation (IQ, OQ, PQ) and their application.
• Experience with Design Master Record (DMR) remediation projects is a plus.