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Senior Mechanical Engineer - Minneapolis, MN

Employer
AtriCure, Inc.
Location
Minneapolis
Salary
Competitive

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This position will lead or work on project teams to plan and support projects including the design, build, and test of next generation medical devices or significant improvements to existing products that are used by cardiac surgeons and electrophysiologists.

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 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, statistics 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 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

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/technicalreport writing skills
Ability to read technical specifications, blueprints 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

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