Process Engineer

Location: Cincinnati, OH
Department: Manufacturing Ops Salaried
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2018-111
Office based or Remote: Office Based

Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib and we have treated over 200,000 patients over the past ten years. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide, with more than 130,000 implanted to date. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

Position Summary:

The Process Engineer is responsible for on-going production, validations, and continuous improvement of new and existing manufacturing processes.  He/she contributes in a creative and collaborative way to achieve the company’s goals of producing market leading products through positive patient outcomes.

 

Roles and Responsibilities:

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

    • Ownership of product assembly line technical performance.  Support production with troubleshooting assembly line issues, resolution of non-conformances, completion of root cause investigations, and CAPA’s. 
    • Collaborate with cross-functional engineering team (quality, product development, regulatory) to address product line issues.
    • Responsible for communication of manufacturing and process issues to cross functional engineering team and suppliers, both verbally and in written documentation.

    • 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, soldering etc.  Understand of error proofing, poke-yoke.
    • Working knowledge of Manual and Automated Assembly Systems and Technologies.
  • Manufacturing Process Knowledge

    • Knowledge of general manufacturing technologies (plastic injection molding, stamping, milling, turning, assembly methods, various fastening techniques) 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

    • Identify and implement manufacturing and product-related cost reduction opportunities.Understand life cycle costs and cost benefit analysis. Apply continuous improvement methods to enhance yield, consistency, performance, capacity, etc. of equipment and processes.

    • Familiar with manufacturing efficiency strategies such as Lean, Six Sigma, 5S, Value Stream mapping, using SPC in resolving/improving productivity and efficiencies etc.

    • Perform process capability assessments and establish methods to control process output.
    • Working understanding of quality statistical models and metrics (confidence/reliability intervals, DOE, regression/trending, SPC, t-Tests, acceptance plans).
    • Able to work in a controlled environment where gowning and strict adherence to clean room procedures are required.
  • 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

    • 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.

    • Working knowledge of Manual and Automated Assembly Systems and Technologies, including both mechanical and control systems

    • Experienced with mechanical equipment and gauges such as microscopes, soldering stations, ovens/furnaces, UV curing stations, Instron, calipers and other measurement gauges.

  • 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 maintaining and updating Process maps and FMEAs.

    • Responsible for writing and executing process qualification protocols and reports.Understanding of Test Method Validation, IQ, OQ, PQ approach as defined by AtriCure Quality System.

  • Manufacturing Logistics

    • Understand supply chains, lead times, and raw material availability

    • 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 conduct time studies and analyze cost variances

  • Troubleshooting and Root Cause Analysis

    • Responsible for evaluating components for conformance to design intent via inspection and functional evaluation

    • Responsible for trending scrap and failure rates, analyzing failure modes, and developing plans to address root cause issues

    • Responsible for supporting ongoing manufacturing on a daily basis to allow them to meet required production goals

    • Responsible for disposition of non-conforming material

  • 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

 

BASIC QUALIFICATIONS:

  • BS degree in Engineering.
  • 5-7 + years of relevant experience.
  • Demonstrated Mechanical and/or Process Engineering ability.
  • Solid understanding of external standards, design controls, quality controls, manufacturing methods.
  • Demonstrates the ability to plan and track tasks to align with project plan and team objectives.
  • Demonstrates excellent written and oral communication skills.
  • Demonstrates excellent ability to work on and influence cross functional teams.
  • Demonstrated ability with data analysis, problem-solving, and troubleshooting.
  • Capable of prioritizing tasks and provide a timely schedule of completion.

 

PREFERRED QUALIFICATIONS:

• Medical device industry experience

• Demonstrated validation experience

• Solid understanding of Industry regulations as it pertains to medical devices

 

ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %):

  • Regularly walk, sit, and push/pull

  • Occasionally stand and bend

  • Regularly lift 10 pounds, occasionally lift 10-50 pounds

  • 5% travel possibility

 

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




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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