Manufacturing Engineer
TLDR
Design validated manufacturing processes and equipment for medical device introductions, capacity expansion, and compliant commercial release.
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.
All your information will be kept confidential according to EEO guidelines.
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