Manufacturing Engineer
Job Description
Job Title: Manufacturing Engineer
Location: 325 Paramount Drive Raynham, MA 02767
Duration: 12 Months Contract
Job Description:
· Develop and implement advanced manufacturing technologies to support new product introductions, site capacity expansion, and transformational initiatives within a regulated medical device manufacturing environment.
· Design manufacturing processes and equipment solutions to ensure manufacturability, scalability, quality, and regulatory compliance from concept through process qualification and commercial release.
· Lead engineering activities and deliverables in support of cross-functional project plans, ensuring alignment with project scope, timelines, and business objectives.
· Author, review, and execute validation lifecycle documentation including User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
· Develop and maintain manufacturing procedures, work instructions, process specifications, and supporting documentation to ensure standardized and compliant operations.
· Coordinate qualification and commissioning activities for manufacturing equipment, automation systems, utilities, and supporting software applications.
· Interface with internal stakeholders and external suppliers to resolve technical issues, manage project deliverables, support equipment implementation, and drive successful project execution.
· Support change control, deviation investigations, root cause analysis, risk assessments, and continuous improvement initiatives to enhance manufacturing performance and product quality.
· Review technical drawings, equipment designs, and vendor documentation to verify compliance with approved requirements and quality standards.
· Ensure compliance with FDA regulations, ISO standards, GMP requirements, quality system procedures, environmental health and safety requirements, and data integrity principles.
Requirements
Function: Production
Experience Level: Mid-Senior Level