Senior Mechanical Engineer

2 weeks ago

Mason, United States AtriCure Full time

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.

POSITION SUMMARY:

This position will contribute to the development of ablation products that treat atrial fibrillation, post operative pain, and/or Left Atrial Appendage (LAA) Exclusion System products. Job performance requires application of technical abilities, command of physics and mechanical engineering, healthcare practices and procedures, and a solid understanding of product development methodologies. Deliverable outputs include analysis, design, evaluation, production transfer, and documentation of products that meet medical and regulatory guidelines. The Senior Mechanical Engineer will play a technical leadership role in the context of multi-disciplinary teams under the direction of a project manager..

ESSENTIAL FUNCTIONS OF THE POSITION:
  • Work in a cooperative cross functional team environment to accomplish personal and team goals and objectives associated with development of innovative medical devices or innovative improvements to existing devices.
  • Support and lead the technical development efforts of medical device projects including requirements development, mechanical design, testing, analysis, verification, and validation
  • Develop component and product technical specifications including the integration and consideration of applicable standards and regulations
  • Support the product development life cycle including needs assessment, Voice of the Customer, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation
  • Develop an understanding of AtriCure devices with an eye for improvement and development projects.
  • Generate work plans, and coordinate activities with product development teams
  • Operate program management tools and documentation requirements of Medical Device Design Controls
  • Perform Analytical modeling / analysis of new technologies in support of achieving product performance requirements
  • Communicate with external suppliers of components, subassemblies and finished assemblies
  • Generate and document intellectual property submissions
  • Understand and practice GD&T and how to properly apply it to yield the desired fits between joining parts.
  • Expertise in computer communication tools, ability to manage design research / development activities through the product life cycle, computer aided engineering tools (Solidworks, FEA software), scheduling (Microsoft project), project documentation, statistical analysis, and intellectual property generation.
  • Perform mechanical analysis including Statics and Dynamics, Finite Element Modeling, and Material Properties
  • Establish understanding of clinical procedures and techniques applicable to AtriCure products
  • Develop and validate test methods
  • Has a knowledge of manufacturing methods and capabilities including plastic injection molding, metal stamping, and metal machining, casting, stamping, forming, grinding, etc.
  • Lead tasks with minimal supervision or guidance
  • Work independently applying comprehensive and diverse engineering principles and practices to broad assignments, including independently leading a moderate project
  • Prioritize tasks and provide a timely schedule of completion
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 required in Engineering or demonstrated equivalent combination of education, training and experience
  • 5+ years of experience in mechanical engineering in medical device product development or equivalent field
  • Must be confident, goal oriented, self-motivated and a team player
  • Must have strong and proven relationship building skills
  • Proven track record of significant technical achievement, capability, and contribution to the success of the business
  • Ability to lead project activity, mentor others, and lead company technical initiatives
  • Experience developing inspection/testing requirements and techniques
  • Data analysis, problem-solving, troubleshooting and formal root-cause analysis experience
  • Proficient acting in integrated process teams, as well as coordinating and communicating customer requirements
  • CAD experience
  • Excellent written and oral communication skills, including scientific/technical report writing skills
  • Ability to read technical specifications, solid models, and drawings
  • Engineering/design background
  • Knowledge of product design, prototyping, and development methodologies, as well as an understanding of healthcare practices and procedures.
  • Track record of generating and documenting intellectual property
  • Solid understanding of industry regulations as it pertains to medical devices, external standards, design controls, quality controls, and manufacturing methods.
  • Demonstrated understanding of the design of medical devices including: design, testing and analysis, verification, and validation
  • Experience in the area of FDA and Regulatory requirements and Standards is required.
  • Proficient knowledge in risk management tools such as FMEAs
  • Demonstrated understanding of test method development
  • Able to work independently on broad tasks and minimal supervision
  • Must be a hands-on, creative problem solver with solid trouble-shooting skills
  • Ability to travel 10%
PREFERRED QUALIFICATIONS:
  • Experience in the design and development of disposable medical devices
  • Record of detailed project management exhibiting comprehensive planning and thorough communication; preferred experience using MS Project as a planning tool
  • Computer networking experience
  • Experience designing products in a regulated industry
  • Expertise in statistical analysis and techniques
  • Understanding of program management tools and expectations of Medical Device Design and manufacturing controls.
  • Understanding of assembly and joining techniques including laser welding, ultrasonic welding, adhesive bonding, over-molding, etc.
  • Computer experience with Microsoft programs such as Project, PowerPoint, Outlook, Excel, and Word
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

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