AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage. Cardiothoracic surgeons are adopting AtriCure’s ablation products for the treatment of AF during concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. AtriCure’s Synergy Ablation System is the first and only device approved by the FDA for the treatment of Persistent and Longstanding Persistent forms of Afib in patients undergoing certain open concomitant procedures.
We are hiring a Project Engineering Manager. This role contributes to the company success through the management of cross-functional team activities. 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-lead products through positive patient outcomes. The Product Engineering Manager will have direct reports and work with other teams/vendors to achieve the project goals.
Application instructions are at bottom of posting.
Roles and Responsibilities:
- Manage cross-functional team activities including technology, development, schedule, resource utilization, budget, and performance validation.
- Generate and manage overall development planning tools including critical specifications (Design Plan, Quality Plan, etc.), management tools (Project Schedule, Tooling / Part / Fixture tracking forms, V&V matrix, etc.) and communication tools (Weekly meeting template, team norms, etc)
- Develop and complete actions in product specifications, technical and logistical requirements, and other disciplines
- Develop a rapport with key customers – surgeons, nurses, and other clinicians
- Develop in-depth understanding of clinical procedures and techniques applicable to AtriCure products
- Create and maintain programmatic and technical documentation to insure efficient planning and execution.
- Aligns and coordinates resources, priorities, work plans, and activities among outside suppliers and the Atricure Product Development group.
- Determines work procedures, prepares work schedules, and expedites workflow.
- Communicate with and direct external suppliers of components, subassemblies and finished assemblies.
- Generate and document intellectual property.
- Review and authorize engineering design changes.
- Develop component and product technical specifications including the integration and consideration of applicable standards and regulations.
- Mentoring of other engineers
- Engineering degree (or equivalent) and 5-7 years’ experience minimum.
- Must know FDA Regulatory Practices.
- Must have experience working with Medical Devices
- PMP certification
- 3+ years of management experience.
- Requires understanding of complete development horizon including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation.
- Requires track record of detailed program management exhibiting comprehensive planning and through communication.
- Requires strong engineering skills and active participation in the technical advancement of the programs.
- Must be proficient acting in and leading integrated process teams, as well as coordinating and communicating customer requirements.
- Able to manage cross-functional team activities including technology development, schedule, resource utilization, budget, and performance validation
- Understanding of complete development horizon including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation.
- Strong engineering skills and active participation in the technical advancement of the programs.
- Understanding of program management tools and expectations of medical device design and manufacturing controls.
For immediate consideration, please apply online: www.atricure.com/product-engineering-manager.
Indeed - 18 months ago