TN Visa Manufacturing Process Engineer Jobs

JOB SUMMARY

Responsible for partnering with the manufacturing, engineering and quality teams in the design, implementation and validation of new processes to manufacture high quality medical devices and associated accessories. Utilizes a variety of tools to continuously improve existing manufacturing while acting as an innovator in the areas of Lean manufacturing processes. Works with in-house personnel to develop test recommendations to ensure that product requirements meet customer expectations and are testable. Works to standardize manufacturing processes and put appropriate controls in place to monitor status. Interacts with product development engineers and is responsible for leading product transfer involving process capability and operator training.

ESSENTIAL FUNCTIONS

• Optimize manufacturing processes to provide sustainable gains in gross margin and product performance through capital projects, statistical analysis, designed experiments, procedural changes, simulation and modeling
• Provide ongoing technical support to production line for equipment, process, or design related issues
• Monitor process and equipment performance; identify and implement process improvement activities to increase/optimize yield, efficiency or throughput
• Maintain safety, product quality, and manufacturing effectiveness by examining equipment, processes, operations, product components and assembly to determine time or quality revisions and suggests/implements improvements
• Work with suppliers and participate in multi-functional teams to resolve technical/quality issues and develop new products
• Participate in new product design and development reviews; suggest ways to enhance DFM; develop process FMEAs; lead transfer of products from design to production; support product scale-up activities
• Drive a Lean culture of continuous improvement; lead and participate in Kaizen events; promote 5s activity to standardize work; work with manufacturing manager to establish task time to maximize throughput, reduce cycle time, identify constraints and balance work content; create and update value stream maps
• Specify, evaluate, select, and implement new equipment and fixtures; develop and execute installation, operation, and performance qualification protocols
• Design and implement validation protocols for process improvements and material changes including comprehensive engineering reports providing analysis of results
• Develop efficient, effective systems for capturing critical process metrics for all manufacturing operations; implement automated data collection where possible
• Comply with all policies and standards
• Any other job responsibilities as assigned by management and subject to modification

QUALIFICATIONS

Any similar combination of Education & Experience is acceptable.

Education

BS in industrial engineering required or
Other technical degree with equivalent experience required

WORK EXPERIENCE

Minimum of 2-4 years’ experience in a commercial manufacturing environment driving continuous improvement with demonstrated experience in use of rotary/converting equipment and automation of manufacturing processes required and
Medical device manufacturing experience with exposure to FDA requirements required and
Production of electromechanical assemblies required

KNOWLEDGE, SKILLS AND ABILITIES

• Experienced in designing and performing process validations
• Works well in dynamic, cross-functional team environment
• Strong analytical skills and common sense with emphasis on a scientific method of problem solving
• Able to model and simulate manufacturing flows
• Able to accept and produce timely results on multiple concurrent projects of significant complexity
• Able to write clear, concise and visual work instructions
• Possess effective verbal and written communication and interpersonal skills to interact with associates at all levels of the organization
• Knowledge of design controls, FDA and MDD requirements; able to work within a medical device quality management system
• Strong project management skills sufficient to take a proposed solution from resource appropriation through project scheduling and execution as well as being able to work as part of a decision-making team to bring about positive change
• Has a fundamental drive for continuous process improvement.

COMPENSATION

The annual salary for this position is:
$85,000.00 to $90,000.00
This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.

EEO STATEMENT

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA

The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.