Medical Devices TN Sponsorship Jobs in Ohio

INTRODUCTION

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

Position Summary

This position will be responsible for the development, qualification, verification and validation of manufacturing processes. The Senior Manufacturing Engineer will contribute in a creative and collaborative way to achieve the company's goals of producing market lead products through positive patient outcomes.

ESSENTIAL FUNCTIONS OF THE POSITION:

Team member of projects involving design and manufacturing resources, both internal and external. Specific expectations include:

• Review of component designs and identification of Design for Manufacturing opportunities. Able to identify critical component functions and determine which manufacturing techniques will provide the optimal outcome. Understands gating and parting line effects on injection molded parts. Able to make cost/benefit trade-offs when determining mold complexity and the use of slides vs. post machining
• Review of proposed component tolerances and input to manufacturing capability. Has knowledge of tolerance capabilities of machining, molding, casting, stamping, forming, grinding, etc. Understands GD&T and how to properly apply it to yield the desired fits between joining parts
• Review of proposed device assembly requirements and identification of Design for Assembly opportunities. Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over-molding, etc. Understanding of error proofing, poke-yoke
• Provide input to systems test requirements for ongoing production
• Definition of high-level manufacturing system/flow
• Selection of suppliers for parts and equipment
• Coordination of parts and equipment fabrication

Manufacturing Process Knowledge

• Knowledge of general manufacturing technologies including low to medium volume manufacturing processes
• Work with outside suppliers to define, document, analyze and qualify their manufacturing processes
• Identify new vendors, processes, materials, and technologies that can be used to improve product quality and reduce product cost
• Lead the definition, development, verification, and validation of manufacturing processes for new products. Develop manufacturing processes that are simple, cost-effective and reliable
• Identify and implement manufacturing and product-related cost reduction opportunities. Understand life-cycle costs and cost-benefit analysis
• Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, etc.

Tooling and Equipment

• Able to define, communicate, and develop fixture concepts using internal and external resources. Able to incorporate the capabilities of typical production association into these concepts
• Understanding of ergonomics as related to repetitive stress injuries
• Work with designers and engineers in the design and development of manufacturing-related equipment and fixtures
• Define and track project tooling and equipment schedule and cost
• Responsible for proper installation of new equipment, and setting up proper preventive maintenance and calibration plans

Verification and Validation

• Responsible for developing detailed process qualification strategies. Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards
• Responsible for developing detailed Process FMEAs and using the output to develop robust manufacturing processes. Also using the output to determine in-process testing and product final inspection requirements
• Responsible for writing and executing process qualification protocols and reports. Understanding of IQ, OQ, and PQ approach as defined by AtriCure Quality System

Manufacturing Logistics

• Understand supply chains, lead times, and raw material availability
• Responsible for make vs. buy decisions on parts and processes
• Able to construct Bills of Material, with proper unit of measure and inventory points
• Working knowledge of MRP and other requirement planning systems
• Able to create manufacturing routers. Understands labor collection and work centers
• Understanding of standard costing and variances. Able to conduct time studies and analyze cost variances

Documentation

• Properly document all work in compliance with AtriCure Quality System requirements
• Responsible for process documentation release using tools such as Visio, Excel, Word, Procal and Master Control documentation release systems
• Write detailed, easy to understand process instructions
• Write detailed test protocols and reports to document qualification activities
• Develop process maps and FMEAs for all processes
• Capable of documenting intellectual property (i.e. Lab Notebook)

Communication

• Responsible for communication of manufacturing and process issues to cross functional development team and suppliers, both verbally and in written documentation
• The individual must have proficiency in computer communication tools and design documentation (Microsoft Office products)

Leadership and Planning

• In charge of planning work to track tasks that align with project plan and team objectives
• Develop and communicate best practices among other manufacturing engineers
• Responsible for guiding the efforts of more junior manufacturing engineers and technicians

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor's degree in engineering (mechanical, industrial, or related field) required or demonstrated equivalent combination of education, training, and experience
• 6+ years of experience in a comparable position
• Able to function as lead manufacturing engineer for product development teams with minimal guidance
• Demonstrates proficiency in selection and qualification of manufacturing processes
• Able to provide input into the design of the product based on manufacturing methods and capabilities
• Able to review product designs relative to achievable component and system tolerances
• Demonstrates proficiency in coordinating the design and development of equipment and fixtures
• Demonstrates proficiency in developing and executing process qualification strategies
• Understands the importance of manufacturing documentation, and sufficient understanding of manufacturing logistics to guide strategy decisions by the design teams
• Conveys ability to work and communicate in a cross-functional environment, including Marketing, Quality, Manufacturing, and Regulatory departments
• Demonstrates the ability to plan and track tasks to align with project plan and team objectives
• Inspection/testing experience
• Data analysis experience
• Computer/data entry skills
• Written/report writing skills
• Verbal communication skills
• Problem solving/troubleshooting experience
• Ability to read technical specifications
• Ability to read blueprints, drawings, and specifications

PREFERRED QUALIFICATIONS:

• Graduate degree
• Assembly and machining experience
• Computer networking experience
• Supervision experience
• Regulatory experience
• Statistical use experience
• Engineering/design background
• Financial analysis experience

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to regularly lift up to 10 pounds, occasionally lift over 10 pounds
• Ability to pass pre-employment drug screen and background check

COMPENSATION

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria.

AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.

AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

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