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.
The Sustaining Engineer will be responsible for the design and development aspects of a project, participating on cross-functional project teams in the post-commercialization phase of the product life-cycle, and assisting the project leader with planning and executing projects or portions of a project for products in commercial use.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Provide engineering support to the Design / Development Engineering, Manufacturing, and Operations departments as required.
- Work with operations and manufacturing to identify opportunities for cost reduction; execute cost reduction initiatives including design, documentation, validation, and production phase-in
- Understanding of and interpreting engineering and production drawings and procedure.
- Provide support to customer service in identifying and addressing critical customer issues.
- Perform complaint investigations and field investigation activities in support of patient/customer safety.
- Ensure timely identification of RMA issues and review for trends to identify root cause and corrective action, as required.
- Investigate production line issues or fielded product issues to determine root cause and to implement solutions
- Regularly review test data and failure trends to eliminate waste and improve product and production capabilities.
- Implement design changes to improve the quality of existing products and/or the customer experience.
- Actively participate on cross-functional teams to address design issues, and support the completion of team deliverables.
- Develop realistic action steps, timetables, and resource estimates for technical projects.
- Develop Test Plans, Test Specifications and Test procedures for system integration, system testing and acceptance testing in order to satisfy product development requirements through verification and validation (V&V).
- Ensure that sustaining engineering projects are completed accurately and on time.
- Stay current with regulatory requirements, and proactively pre-empt obsolescence.
- Perform technical evaluations related to supplier and manufacturing changes to existing products, as well as, identification and qualification of new suppliers
- Communicate effectively and review project outcomes with internal/external customers as applicable
- Performs other special projects and functions as assigned.
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Ability to work under fast-paced conditions with ability to meet committed deadlines
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Ability to work in an ever-changing environment
- Additional duties as assigned
- Bachelor’s Degree in Engineering discipline: Electrical, Software, Systems, or Biomedical
- Minimum 7 years of professional engineering experience developing and performing SW/HW Integration or System level test.
- 5+ years of hand-on professional experience in Medical Device design and manufacturing of capital equipment
- Able to perform all tasks to the formal quality of standards put into practice within the company’s Quality Management System (QMS).
- Strong understanding of engineering fundamentals, and an ability to deconstruct real world issues into root engineering causes.
- Strong communication and interaction skills, with the ability to work with surgeons and sales/marketing personnel.
- Experience with non-conformances, CAPAs, and product complaint investigations. Experience troubleshooting product issues and applying root cause analysis tools preferred.
- Understanding of engineering methodology for product reliability and associated validation testing
- Experience writing technical documents such as impact assessments, technical memos, and other engineering documentation is required.
- Strong verbal and written communication skills.
- Ability to build strong working relationships cross-functionally
- Ability to work independently or as part of a team
- Ability to analyze and identify trends
- Experience in medical device industry and knowledge of Regulatory Design Controls is desirable.
- Excellent problem-solving skills
- Ability to travel up to 10%
- Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971 is preferred.
- Knowledge of medical compliance such as 60601-1 family of regulations, RoHS, REACH, etc
- Uses problem solving techniques such as DMAIC to resolve issues as they arise
- Leading projects / activities in groups
- Experience with product support both domestically as well as internationally
- Ability to manage multiple projects and timelines.
- Ability to regularly walk, sit, or stand as required
- Ability to occasionally bend and push/pull
- Ability to regularly lift up to 25 pounds, occasionally lift up to 50 pounds
- Ability to pass pre-employment drug screen and background check