Write and execute validation protocols and reports (IQ, OQ, PQ).
Develop and implement manufacturing processes, specifications, operator instructions, process studies, and production readiness activities.
Conduct investigations, root cause analysis, problem solving, and prepare reports/presentations.
Update procedures, manufacturing specifications, bills, routes, and travelers for product/process changes in PLM systems.
Work with equipment manufacturers and distributors to develop user requirements.
Partner with Operations, OpEx, Planning, Engineering, and Quality teams to align validation strategy, author documents, coordinate execution, and manage approvals.
Ensure adherence to FDA regulations, regulatory requirements, company policies, and operating procedures.
Identify opportunities for process improvement and implement best practices.
Maintain positive and cooperative communication with employees, customers, contractors, and vendors.
Background in medical device or other regulated industries.
Experience with machining, metal finishing, laser processing, or production automation.
Practical exposure to machining, casting, finishing, laser processing, or automation.
Knowledge of statistical data analysis tools (e.g., Minitab).
Basic understanding of Geometric Dimensioning and Tolerancing.
Willingness to support global projects, including travel.
Requirements:
2-4 years of experience in manufacturing and/or process engineering.
Strong technical writing skills with awareness of intended audience.
Ability to effectively communicate with operators, peers, and management in both written and oral formats.
Handson experience with validation protocols.
Experience in medical device and/or regulated manufacturing environment.
Interpersonal Skills:
Persuasive communication and strong interpersonal abilities.
Proficiency with Microsoft Office tools.
Numbers & Facts
Location
Raynham, MA
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Skills
Automationunmatched
Best Practicesunmatched
Castingunmatched
Communication Skillsunmatched
Corporate Policiesunmatched
Data Analysisunmatched
Distribution Channelunmatched
FDA Requirementsunmatched
Geometric Dimensioning and Tolerancingunmatched
Interpersonal Skillsunmatched
Machiningunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Process Engineeringunmatched
Manufacturing Requirementsunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Microsoft Officeunmatched
Minitabunmatched
Operational Expenditure (OPEX)unmatched
Operations Processesunmatched
Persuasion Skillsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Engineeringunmatched
Process Improvementunmatched
Process Validationunmatched
Product Lifecycle Managementunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Reporting Skillsunmatched
Requirements Managementunmatched
Root Cause Analysisunmatched
Statisticsunmatched
Technical Writingunmatched
Validation Planunmatched
Writing Skillsunmatched
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