Senior Manufacturing Engineer

Laborie Medical Technologies Corp•Plymouth, MN

26d

About The Position

As a key member of the Operations team, the Senior Manufacturing Engineer is responsible for assisting in the development, qualification, launch of new products and updates to existing medical devices into manufacturing. The Senior Manufacturing Engineer thrives in cross-functional teams, and they will work closely with various stakeholders across multiple departments to ensure efficient design transfer processes. With experience in lean manufacturing environments and relevant product knowledge, the Senior Manufacturing Engineer helps improve manufacturing processes and explore new ideas.

Requirements

Master's degree, or equivalent, in Biomedical, Mechanical, or Industrial Engineering or related field, and 5 years relevant experience, or Bachelor's degree and 8+ years relevant experience
Manufacturing, quality, and product development
Experience with catheters, balloon catheters, bonding processes, including manufacturing and testing processes
Working with ISO 13485/ISO 9001
Working within a controlled medical device environment
Proven experience and knowledge in design controls, device design and development standards, FDA regulation, GMP practices and QSR requirements
Project management skills including development of project plans, schedules and budgets, including strong communication skills, ability to manage communication with cross functional teams and external contractors and ability to effectively present technical information.
Working knowledge of DFM (Design for Manufacturability), Six Sigma, and Lean manufacturing practices.
Strong hands-on technical aptitude, with ability to troubleshoot equipment, recommend corrective actions and implement solutions
25-50% domestic travel first year; approximately 10% domestic and/or international travel after year one.

Nice To Haves

Preferred knowledge of combination medical devices and injection molding processes
Green Belt certification and Lean Six Sigma certifications
Knowledge of technology transfer/product line transfer

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.