POSITION SUMMARY:The Associate Engineer will contribute to the company’s success through the development and delivery of innovative medical devices. This position reports to Product Development Management in the Ablation Franchise. This position contributes in a collaborative way with management, project teams, production associates, external vendors and other work groups to achieve the company’s goals of producing market-leading products that generate positive patient outcomes.ESSENTIAL FUNCTIONS OF THE POSITION:
Execute development tasks to include design, development, and formal testing of medical devices.
Develop and validate test methods for new product features and functions.
Participate in input / feedback from key customers – surgeons, nurses, and other clinicians.
Establish understanding of clinical procedures and techniques applicable to AtriCure products.
Generate protocols and plans for verification and validation studies, and provide direct support in the studies.
Operate and maintain engineering laboratory systems and equipment.
Create and maintain concise technical documentation.
Generate individual work plans, and coordinates activities with product development teams.
Contribute to the generation and documentation of intellectual property.
Perform a variety of engineering design and development tasks, to include design, analysis, prototyping, first-article inspections, in-vivo and in-vitro testing, and user validation.
Generate / document engineering design changes.
May mentor engineering students / co-ops.
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 Engineering (mechanical or biomedical preferred).
Knowledge of Design Controls and FDA QSR 21 Part 820 and ISO13485
Demonstrated understanding of protocol/report writing.
Must have proficiency in planning work in support of cross-functional team environment.
Requires engineering aptitude and active participation in the technical advancement of the programs.
Able to evaluate scientific options, establish work schedules and estimate resource requirements.
Skilled in written and oral communication.
Trained in data analysis, problem-solving, troubleshooting and formal root-cause analysis techniques.
Capable of prioritizing tasks and provide a timely schedule of completion.
Ability to travel 20%
PREFERRED QUALIFICATIONS:
BS degree in a technical field with 2+ years of medical device experience is preferred.
Experience using MS Project to schedule and manage tasks in development projects.
Proven track record of generating and documenting development tasks, protocols, and reports.
Experience in the development of capital equipment as well as single-patient use disposables.
Experience in PMA and 510k device development.
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
