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Senior Manufacturing Engineer Job in Cincinnati, Ohio US

Senior Manufacturing Engineer

Atricure, Inc. - Cincinnati, OH

Posted: 5/6/2024 - Expires: 8/4/2024

Job ID: 273219541

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Job Description

Senior Manufacturing Engineer

Cincinnati, OH, USA * Mason, OH, USA
Req #1940

Wednesday, May 1, 2024

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 worksite attendance
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 required or demonstrated equivalent combination of education, training and experience.
7+ 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
Ability to travel 5%

PREFERRED QUALIFICATIONS:


Graduate degree
Assembly experience
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 required
Ability to occasionally bend and push/pull
Ability to regularly lift up to 10 pounds, occasionally lift over 10 pounds
Ability to pass pre-employment drug screen and background check

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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, 20 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. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits 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 https://www.e-verify.gov/ 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).

Other details

Job Family
Manufacturing Engineering

Job Function
Operations

Pay Type
Salary

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
79307730
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 6
Graphic Literacy: 6

Workplace Documentation: 5