Manufacturing Engineer III

2 weeks ago

Chelmsford, United States Medix™ Full time

Position Summary

The Manufacturing Engineer III will support engineering and quality compliance efforts across the business. The primary function of the Manufacturing Engineer III is to offer daily engineering support for manufacturing operations. This includes investigating non-conforming products and managing Non-Conformance (NC) tasks. The role also involves leading continuous improvement projects aimed at cost reduction while ensuring quality compliance through lean problem-solving tools. Responsibilities include maintaining good documentation practices, adhering to design control processes, and other necessary documentation methods. Proficiency in IQ/OQ/PQ and P/DFMEA is required, and experience with Lean Principles is preferred.


Principal Responsibilities

  • Production Metrics: Ensure and sustain production-specific metrics such as yield and efficiency.
  • Non-Conformance Investigations: Lead investigations related to Non-Conformances, Complaints, and CAPA. Serve as a team member or leader as needed for technical assistance.
  • Engineering Actions: Lead engineering actions identified through production visual management boards.
  • Project Management: Source, plan, present, and deliver significant projects aimed at reducing waste, increasing productivity, and reducing operational stress. Demonstrate competency in Six Sigma and Lean Tools associated with the Production System.
  • Documentation: Create and update manufacturing and engineering documents (Work Instructions, SOPs, Specifications, Engineering Drawings, etc.), and provide necessary training.
  • Process Qualification and Validation: Demonstrate competence in process qualification and validation activities, including authoring and executing validation plans, engineering studies, IQ, OQ, PQ, and Test Method Validation (TMV) per ISO, FDA, and corporate guidelines.
  • R&D Support: Support R&D activities, providing technical input to projects and managing the transfer process from design to manufacturing, ensuring cost-efficient production capabilities.
  • Project Management Skills: Define project scope, identify measurable results, methods, and resources for improvement, manage timelines, and deliver capable results.
  • Technical Changes Coordination: Coordinate with production management to plan and implement necessary technical changes to maintain production line capacity.
  • Leadership and Mentoring: Provide technical leadership, mentoring, and supervision of Manufacturing Technicians.
  • Additional Duties: Perform additional duties as requested to support the organization's needs.

Education / Experience Requirements

  • Bachelor's degree in Engineering, preferably Mechanical Engineering.
  • Minimum of 3-5 years’ experience in manufacturing support, preferably in medical devices.
  • Experience with FDA QSR process and validation documentation is a plus.

Specialized Skills / Other Requirements

  • Proficiency in IQ/OQ/PQ and P/DFMEA.
  • Project management experience with a track record of meeting schedule and budget targets.
  • Experience in developing production test fixtures is desirable.
  • Proficient in common PC applications (Word, Excel, etc.).
  • Knowledge of Agile and SAP is a plus.
  • Familiarity with Six Sigma and Lean manufacturing is a plus.
  • Excellent communication, organization, and interpersonal skills.
  • Ability to complete tasks and projects with minimal supervision.
  • Capability to mentor Technicians and other Engineers.
  • Effective communication skills with a wide variety of internal and external customers and suppliers.

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