Manufacturing Engineer

About the role

Job Title: Manufacturing Engineer
Reports To: Manager, Manufacturing Engineering
Location: Houston (onsite)
Business Unit Description: Foot & Ankle
High-Level Position Summary: We're looking for a Manufacturing Engineer to help Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

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

Requirements

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

Qualifications

• 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
• Knowledge of GD&T ASME Y14.5MM
• Master’s degree in engineering and/or metals/plastics machining experience a plus

Skills

• Problem Solving and Process Improvement Methodologies (e.g. 6 Sigma)
• Data Analysis (Minitab)
• General Computer Programs (Microsoft Office)
• Measurement Systems (CMM’s, Vision Inspection and Profilometers)
• CAD Software (Solid Works, MasterCAM, AutoCad)
• FDA Regulations (21CFR 820)
• ISO Standards (ISO 13485)
• GD&T ASME Y14.5MM

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation, Sick Leave, and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

Pay

Details TBD

Schedule

Details TBD