Manufacturing Engineer
Job Location:
Raynham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
About Company
At Fusion Plus Solutions Inc, we believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, f ... View more
