manufacturing Engineer

Roles & Responsibilities:

• Writing and execution of validation protocols and reports (i.e. IQ, OQ, PQ, etc.).
• Developing and implementing manufacturing processes, preparation of specifications and operator instructions, process studies, production readiness, investigations, root cause analysis, problem solving and report or presentation preparation.
• Updating procedures, manufacturing specifications, bills, routes and travelers for product & process changes in the PLM system.
• Working with OEM equipment manufacturers and distributors to develop user requirements.
• Work on new asset commissioning Working with multi-functional teams (Operations Value Stream, Op Ex, Planning, Engineering, and Quality) to align on validation strategy, author validation documents, coordinate execution and document approvals.
• Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments when supporting projects.
• Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

• 2-4 years of experience in manufacturing and/or process engineering.
• Strong technical writing skills, with appropriate awareness of intended audience.
• Ability to effectively communicate across multiple audiences, including operators, peers and management, in both written and oral manners Process validation experience.
• Experience in a Medical Device and/or regulated manufacturing work environment.
• Persuasive communication and interpersonal skills.
• Digital literacy, including use of Microsoft Office tools.
• Experience working in a regulated industry, such as Medical Device.
• Experience with machining processes, metal finishing processes, laser processing or production automation.
• Hands-on experience with machining processes, casting, metal finishing processes, laser processing or production automation.
• Knowledge of statistical data analysis and associated tools (e.g. Minitab).
• Basic knowledge of Geometric Dimensioning and Tolerancing (GD&T).
• Willingness to support global projects, which may include travel.