Staff Manufacturing Engineer

Posted 3 Days Ago
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Mason, OH, USA
In-Office
Expert/Leader
Healthtech
The Role
Lead development, validation, and continuous improvement of medical device manufacturing processes. Define processes and tooling for new products and suppliers, apply DFM/DFA and lean principles, perform risk management (Process FMEA), specify equipment/fixtures, coordinate prototypes/pre-production, manage projects and mentor junior engineers to meet quality, cost, and capacity targets.
Summary Generated by Built In

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:

The Staff level Manufacturing Engineer is a highly experienced manufacturing/process engineer, responsible for developing, validating and maintaining capable and stable manufacturing processes to meet product quality standards/requirements.   The role is responsible for defining the manufacturing processes required to bring new products to market, both internally at AtriCure, and externally at key suppliers, as well as defining and implementing improvements to existing manufacturing processes.  A Staff Manufacturing Engineer may lead project teams and will contribute to the coaching and development of less senior engineers.


ESSENTIAL FUNCTIONS OF THE POSITION:

  • Ensures continuous improvement in process, cost, quality and production
  • Responsible for coaching/mentoring members of the Manufacturing/Process Engineering Teams
  • Supports and drives a DFM focused culture within the PD teams and the operations organization
  • Supports and drives a continuous improvement culture within the PD teams and the operations organization

Represents manufacturing on cross functional projects, both internal and external.  Specific expectations include:

  • Defines high level manufacturing system/flow requirements and selects appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets.
  • Collaboration with product design engineers to identify and implement Design for Manufacture/Design for Assembly improvements.
  • Has knowledge of tolerance capabilities of processes such as machining, molding, casting, stamping, forming, grinding, etc.  Understands GD&T and how to properly apply it to yield the desired fits between joining parts
  • Applies lean manufacturing (Toyota production system) principles to the design of manufacturing processes, facilities layouts and business processes associated with manufacturing. 
  • Participates in development of product requirements and leads manufacturing risk management activities (Process FMEA, Validation Master Plan, Inspection and Test methods)
  • Selection of suppliers for parts and equipment.
  • Coordination of prototype and pre-production builds.
  • Specifies, designs and manages procurement of equipment, fixtures and tooling.
  • Applies project management best practices to manufacturing engineering projects including development of work breakdown structures, identification of required resources, budgeting and management of required expenses, and daily task and resource management to achieve expected project outcomes.

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 Industrial Eng., Biomedical Engineering or Mechanical Eng. or equivalent is required
  • 10+ years of related experience:
  • Experience in development of new manufacturing processes and the tooling/equipment required to implement the processes
  • Knowledge base in Lean Processes and Continuous Improvement
  • Experience in Design for Manufacturability
  • Experience with medical device design and manufacture
  • Previous class II or class III Medical Device manufacturing experience
  • Possess a strong knowledge of manufacturing processes and capabilities.  Provide guidance in process and supplier selection when necessary.
  • Self-motivated with strong time management skills
  • Ability to translate broad strategies into specific objectives and action plans
  • Experience in technical report writing and verbal and oral communication skills
  • Must be able to read blue prints and interpret technical specifications and illustrations
  • Comfortable driving multiple initiatives at a rapid pace
  • Creative thinker with exceptional process, analytical, management and relationship skills
  • Problem solving/trouble shooting experience                                                                                                                              

PREFERRED QUALIFICATIONS:

    • N/A

OTHER REQUIREMENTS:

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

#LI-KS1     #LI-ONSITE

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

You may access our global privacy policy here: https://www.atricure.com/privacy

Skills Required

  • Bachelor's degree in Industrial, Biomedical, Mechanical Engineering or equivalent
  • 10+ years of related manufacturing/process engineering experience
  • Experience developing new manufacturing processes and associated tooling/equipment
  • Knowledge of Lean Processes and Continuous Improvement (Toyota Production System)
  • Experience with Design for Manufacturability / Design for Assembly
  • Experience in medical device design and manufacture (Class II or Class III)
  • Strong knowledge of manufacturing processes and process/supplier selection
  • Experience with Process FMEA, Validation Master Plans, inspection and test methods
  • Ability to specify, design, and manage procurement of equipment, fixtures, and tooling
  • Ability to read blueprints and interpret technical specifications and GD&T
  • Technical report writing and strong verbal and written communication skills
  • Problem solving and troubleshooting experience; ability to drive multiple initiatives
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The Company
HQ: Mason, Ohio
720 Employees

What We Do

AtriCure provides innovative atrial fibrillation (Afib) solutions designed to produce outcomes that reduce the economic and social burden of Afib.

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