Manufacturing Engineer

Laborie Medical Technologies Corp•Plymouth, MN

49d

About The Position

As a key member of the Operations team, the Manufacturing Engineer supports and enhances production operations by improving quality, reducing defects, and resolving non-conforming material issues within a controlled environment certified to ISO 9001 and regulated by ISO 13485. The Manufacturing Engineer plays a key part in the development, qualification, and launch of new products, as well as updates to existing medical devices, ensuring efficient and compliant design transfer into manufacturing. Working closely with cross-functional teams, the Manufacturing Engineer applies lean manufacturing principles, technical expertise, and strong problem-solving skills to optimize processes, drives continuous improvement, and introduces innovative ideas that enhance operational performance and product reliability.

Requirements

Bachelor's degree, or equivalent, in Biomedical, Mechanical, or Industrial Engineering or related field, and 2+ years of experience as a Manufacturing Process Engineer
Lean manufacturing methods and procedures
Working with ISO 13485/ISO 9001
Working in medical device environment, GMP practices
Manufacturing quality and product development
Project management
Knowledge of DFM (Design for Manufacturability), Six Sigma Green Belt and Lean Six Sigma
Working with ERP systems
Strong problem-solving skills using structured methodologies (5-Why, Fishbone, DMAIC, etc.)
Solid written and verbal communication skills; able to manage communication within cross functional teams and external contractors
5% domestic and/or international travel potential

Responsibilities

Design manufacturing processes, procedures, and production layouts to optimize productivity, maintainability, and cost for drug-device combination products.
Optimize drug coating, manufacturing, and packaging processes, improve process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on platform or derivative projects.
Actively participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTG) reviews assuring specifications are well defined and documented; participate/lead Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.
Manage and support line validation/qualification activities including IQ, OQ, MSA and PQ, including authoring all related documentation and execution of testing protocols.
Actively participate in Lean initiatives to stabilize production lines, reduce waste, and improve manufacturing efficiency. Calculate production, labor, and material costs and review production schedules to make data-based decisions for improvements.
Create and review process flow charts, production tooling strategies, production line layouts, production capacity analysis, and EHS project plans.
Prepare documentation including: testing protocols for product evaluations, work instructions, Control Plans, Manufacturing Processes, job safety analysis sheets, and product and process reports.