Kaztronix LLC ยท 1 day ago
Manufacturing Process Engineer
Raynham, MA
Contract
Onsite
Entry, Mid Level
2+ years expKaztronix LLC is seeking a Manufacturing Process Engineer to develop and implement manufacturing processes while ensuring compliance with FDA regulations. The role involves writing validation protocols, updating specifications, and collaborating with multi-functional teams to align on validation strategies.
ConsultingInformation TechnologyStaffing Agency
Hiring Manager
Danny Wolford
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
Qualification
Required
Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree
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
Preferred
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
Company
Kaztronix LLC
Kaztronix is a staffing and recruiting company that provides specialty consulting solutions.
201-500 employees
H1B Sponsorship
Kaztronix LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Michael Kasmir
Managing Member & Co-Founder
Company data provided by crunchbase