Senior Mechanical Engineer

Position Summary

This position will contribute to the development of ablation products that treat atrial fibrillation, postoperative 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

• 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.
• Have 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

• 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 an 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 with minimal supervision.
• Must be a hands‑on, creative problem‑solver with solid troubleshooting 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.