Manufacturing Engineer

Role Description s:
Must Have Technical/Functional Skills

· 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.

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, OpEx, 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.

Generic Managerial Skills, If any

· 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

Key Words to search in Resume

validation protocols, IQ, OQ, PQ, manufacturing processes, process studies, new asset commissioning,