Manufacturing Engineer

1 month ago


Norwood, United States Kelly Science, Engineering, Technology & Telecom Full time

Manufacturing Engineer - Norwood, MA


JOB DESCRIPTION:

We are seeking a highly motivated, very hands-on, and skilled manufacturing engineer to join our dynamic team. This engineer will be the technical subject matter expert for our production equipment, who leads new equipment, technology integration, and continuous improvement projects and will spend 30% - 70% of their time in our production areas. Travel will be limited to project-related activities.


This is a full-time, onsite engineering role on our campus in Norwood, MA.


RESPONSIBILITIES:

  • Researches equipment and technology solutions and provides input on technology roadmaps.
  • Oversees new technology implementation and integration and process automation projects.
  • Leads new equipment projects, includes developing capital requests, user requirements, floor layout, and project plans, overseeing FAT, equipment installation, SAT, qualification, and production start-up.
  • Establishes PMs and spare parts list for new equipment with supplier and AP maintenance team.
  • Collaborates with scheduling, supervisor/lead, and process engineer/technician on machine cycle times, capacity, and capabilities and consulted on machine issues, troubleshooting, & resolution.
  • Complete continuous improvement projects to optimize and standardize equipment and output.
  • Establishes critical equipment functionality and performance monitoring needs to ensure products meet or exceed customer requirements.
  • Develops fixture designs and quick changeover solutions.
  • Leads kaizen and process mapping activities as needed.
  • Collaborates with process engineers on current and future state (3P) value stream layouts.
  • Supports and leads EHS projects as necessary.
  • Develops initial operator on the job training and work instructions for new technologies.
  • Provides technical training to operators, process technicians, and engineering team as needed.
  • Develops key process metrics and controls and can utilize an MRP system as needed.
  • Performs other related duties as assigned by management.


REQUIREMENTS

  • The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation.
  • Minimum 1 year of hands-on manufacturing engineering experience, preferably in the medical device and or other highly regulated industry, like aerospace and/or defense industry.
  • Experience in complex electro-mechanical equipment applications, automation application, and PLC controls and programming are a plus.
  • Proficient knowledge and application of GMPs & ISO 13485 system requirements, and knowledge of equipment qualifications tools (i.e., IQ, OQ, & PQ).
  • Experienced in using CAD to develop fixture designs and building/equipment layouts.
  • Knowledge of both polymer and metal materials is a plus.
  • Knowledgeable in OSHA regulations and complies with EHS policies and procedures.
  • Must be customer focused, have a strong quality mindset, and make effective risk-based decisions.
  • Able to successfully manage complex projects and has experience in driving technology integration, new equipment, and continuous improvement projects and strategies.
  • Possesses practical experience Lean and Six Sigma; certifications are a plus.
  • Must be able to work in a fast-paced cross-functional team environment, with minimal supervision, and effectively communicate and present to all levels of an organization.
  • Possesses excellent interpersonal skills along with strong analytical, change management, critical thinking, attention to detail, influencing, and problem-solving skills.
  • Able to perform technical writing, develop training, quality procedures, databases, and dashboards.
  • Demonstrates good financial and business acumen, able to manage capital projects.
  • BS or advance degree in mechanical, electro-mechanical, or chemical engineering is preferred.


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