Manufacturing Engineer

Enovis•Houston, TX

2d•Onsite

About The Position

As a key member of the Manufacturing Engineering team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. We are looking for a Manufacturing Engineer responsible for the design and development of new and/or improved manufacturing processes and ensuring efficient and effective design transfer of product into production. You will be part of the cross-functional team to lead/manage all aspects of process development to implement manufacturing processes. Drive improvements to existing manufacturing processes, which then may be shared across other platforms. Join this great team for an opportunity to work in the exciting Medical Device Industry.

Requirements

Bachelor’s degree in science or BSME, or related Engineering Degree
A minimum of 2 years of experience in process/manufacturing engineering role

Nice To Haves

Excellent mechanical aptitude, good communication and interpersonal skills
Previous experience in an orthopedic medical device manufacturing setting
Previous experience in the areas of Design for Manufacturing (DFM), Lean Manufacturing, and Process Control Concepts, Design of Experiments (DOE), Process Validation and product/process Failure Mode and Effects Analysis (FMEA)
Use of Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma)
Experience with data analysis (Minitab) preferred
Proficient in general computer programs such as Microsoft Office
Experience with Measurement Systems (CMM’s, Vision Inspection and Profilometers)
Experience with CAD Software (i.e. Solid Works, MasterCAM, AutoCad)
Knowledge of FDA regulations (21CFR 820), ISO standards (ISO 13485), MDD, CMDR and other regulations as applicable
Experience with GD&T ASME Y14.5M
Master’s degree in engineering and/or metals/plastics machining experience a plus

Responsibilities

Manage the adherence to prescribed procedures to ensure product quality meets or exceeds planned goals
Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators
Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
Serves on cross functional teams as a manufacturing expert on new product introductions
Assure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes
Executes the functional deliverables associated with the CAPA, Project Management, and Quality Systems
Ensures proper documentation is completed to meet quality systems requirements (e.g., BOM’s, Routers, FMEA’s, etc.)
Writes and reviews validation protocols and reports applicable to new processes
Maintain equipment by coordinating maintenance and repair services and following manufacturer’s instructions and established procedures
Train applicable staff on testing and manufacturing processes associated with each company product
Participate in quality control/assurance related activities
Participate in Kaizen events and Lean initiatives
May coach technicians or other engineering support employees