Senior Manufacturing Engineer

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. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

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 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, an